WAYNE PNEUMOTHORAX TRAY

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D4 - LOT#, PRIMARY UDI NUMBER, EXPIRATION DATE; H4 - DEVICE MFG DATE. INVESTIGATION ¿ EVALUATION: IT WAS REPORTED THAT THE STRAIGHTENING OBTURATOR FROM A WAYNE PNEUMOTHORAX TRAY (RPN: C-UTPTY-1400-WAYNE-112497-IMH; LOT #: UNKNOWN) WAS INADVERTENTLY LEFT IN THE CATHETER. THE CHEST TUBE FROM A WAYNE PNEUMOTHORAX TRAY WAS PLACED FOR A 67-YEAR-OLD MALE WITH A PAST MEDICAL HISTORY OF COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE) WHO PRESENTED TO THE EMERGENCY DEPARTMENT WITH WORSENING SHORTNESS OF BREATH. IMAGING SHOWED A LARGE RIGHT PNEUMOTHORAX. A CHEST TUBE WAS PLACED, A CHEST X-RAY WAS COMPLETED, AND IT WAS NOTED THE PATIENT EXPERIENCED RELIEF. PULMONARY WAS CONSULTED FOR FURTHER EVALUATION. LATER, THE PATIENT COMPLAINED OF SHORTNESS OF BREATH, DIFFICULTY BREATHING, AND NECK SWELLING. AN RRT (REGISTERED RESPIRATORY THERAPIST) WAS CALLED DUE TO RESPIRATORY DISTRESS. THE PATIENT WAS STARTED ON A NON-REBREATHER MASK AND EXPERIENCED SOME RELIEF; A REPEAT CHEST X-RAY WAS OBTAINED WHICH SHOWED NO SIGNIFICANT INTERVAL CHANGE. HOWEVER, ASSESSMENT NOTED THERE WAS STILL SOME AIR-LEAK IN THE CHEST TUBE/PLEURAL VAC. THEN IT WAS DISCOVERED THAT THE STRAIGHTENING OBTURATOR WAS INADVERTENTLY LEFT IN THE CHEST TUBE. THE OBTURATOR WAS REMOVED, AND THE CHEST TUBE WAS REATTACHED TO THE DRAINAGE SYSTEM. THE PATIENT REPORTED FEELING BETTER AND SYMPTOMS IMPROVED. A STAT CT OF THE CHEST WAS THEN OBTAINED, WHICH SHOWED THE RIGHT PLEURAL PIGTAIL CATHETER IN PLACE, WITH A SMALL RIGHT APICAL PNEUMOTHORAX, EXTENSIVE ASSOCIATED PNEUMOMEDIASTINUM, AND SUBCUTANEOUS EMPHYSEMA IN THE BASE OF THE NECK AND CHEST WALL. REVIEWS OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), QUALITY CONTROL PROCEDURES, AND INSTRUCTIONS FOR USE (IFU), WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER; HOWEVER, COOK COMPLETED A SALES SEARCH FOR THE CUSTOMER FOR THE LAST 3 YEARS AND IDENTIFIED ONE LOT SOLD TO THE CUSTOMER. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO QUALITY CONTROL DISCREPANCIES FROM THE COMPLAINT DEVICE LOT. A COMPLAINT HISTORY SEARCH DID NOT IDENTIFY ANY OTHER EVENTS ASSOCIATED WITH THE DEVICE LOT. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION AND THAT THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE IFU SUPPLIED WITH THE DEVICE STATES THE FOLLOWING IN CONSIDERATION OF THE REPORTED FAILURE MODE: INSTRUCTIONS FOR USE: ¿9. REMOVE THE WIRE GUIDE AND CATHETER OBTURATOR. ATTACH CATHETER TO CONNECTING TUBE WITH STOPCOCK, AND COOK CHEST DRAIN VALVE. ATTACH COOK CHEST DRAIN VALVE IN DIRECTION INDICATED BY ARROW ON VALVE. NOTE: CHEST DRAIN VALVE MAY BE OBVIATED IF CATHETER IS TO BE CONNECTED TO A WATER SEAL SUCTION APPARATUS OR SIMILAR MECHANICAL SUCTION DEVICE. DO NOT CONNECT CATHETER DIRECTLY TO WALL SUCTION.¿ BASED ON THE AVAILABLE INFORMATION, NO PRODUCT RETURNED, AND THE RESULTS OF THE INVESTIGATION, COOK CONCLUDES UNINTENDED USE ERROR IS THE CAUSE FOR THIS EVENT. THE IFU PROVIDES INSTRUCTIONS FOR REMOVING THE OBTURATOR AFTER PLACEMENT. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

Description of Event or Problem

NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

Description of Event or Problem

IN ADDITIONAL INFORMATION RECEIVED ON 02DEC2025, IT WAS REPORTED THAT THE PATIENT DESATURATED AS A RESULT OF THE FAILURE. NO ADDITIONAL PROCEDURES WERE NEEDED ONCE THE STRAIGHTENER WAS REMOVED, PER THE FOLLOW UP X-RAY.

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. ADDITIONAL INFORMATION: B5, H6 - ANNEX E. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: A2, A3, A4, A6, B5, B7, G2, H6 -ADDITIONAL ANNEX E CODE. CORRECTION: B2. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

Description of Event or Problem

PER THE FDA MW5176916 RECEIVED 30OCT2025: THIS IS A 67-YEAR-OLD MALE WITH A PAST MEDICAL HISTORY OF COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE). HE INITIALLY PRESENTED TO THE ED (EMERGENCY DEPARTMENT) WITH WORSENING SHORTNESS OF BREATH. IMAGING NOTED A LARGE RIGHT PNEUMOTHORAX. HE UNDERWENT CHEST TUBE PLACEMENT IN THE ED. PULMONARY WAS CONSULTED FOR FURTHER EVALUATION. A PHYSICIAN WAS CALLED EMERGENTLY TO BEDSIDE BY THE HOSPITALIST TEAM AS THE PATIENT WAS COMPLAINING OF SHORTNESS OF BREATH, NECK SWELLING, DIFFICULTY WITH BREATHING, AND WAS NOTED TO HAVE EXTENSIVE SUBCUTANEOUS EMPHYSEMA AROUND THE NECK. AN RRT (REGISTERED RESPIRATORY THERAPIST) WAS CALLED DUE TO RESPIRATORY DISTRESS. HE WAS STARTED ON A NON-REBREATHER MASK WITH SOME RELIEF; A REPEAT CHEST X-RAY WAS OBTAINED WHICH SHOWED NO SIGNIFICANT INTERVAL CHANGE. ON ASSESSMENT, THERE WAS STILL SOME AIR LEAK IN THE CHEST TUBE; HOWEVER, THE CHEST TUBE STYLET APPEARED TO STILL BE IN PLACE. IT WAS REMOVED AND THE CHEST TUBE WAS REATTACHED TO THE CHEST DRAINAGE SYSTEM WITH INCREASED AIR LEAK. THE PATIENT STATED THAT HE WAS STARTING TO FEEL BETTER. A STAT CT OF THE CHEST WAS THEN OBTAINED, WHICH SHOWED THE RIGHT PLEURAL PIGTAIL CATHETER IN PLACE, WITH A SMALL RIGHT APICAL PNEUMOTHORAX, EXTENSIVE ASSOCIATED PNEUMOMEDIASTINUM, AND SUBCUTANEOUS EMPHYSEMA IN THE BASE OF THE NECK AND CHEST WALL.

Additional Manufacturer Narrative

E3: OCCUPATION: DIRECTOR RISK MANAGEMENT. G4: PMA/510(K) #: EXEMPT. H3: DEVICE EVALUATED BY MFG? NO DEVICE RETURN TO MANUFACTURER. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

Description of Event or Problem

IT WAS REPORTED THAT THE STRAIGHTENING OBTURATOR FROM A WAYNE PNEUMOTHORAX TRAY WAS INADVERTENTLY LEFT IN THE CATHETER. THE CHEST TUBE FROM A WAYNE PNEUMOTHORAX TRAY WAS PLACED IN THE EMERGENCY DEPARTMENT FOR AN UNKNOWN PATIENT WHO PRESENTED WITH A LARGE RIGHT PNEUMOTHORAX. AN INITIAL CHEST X-RAY WAS COMPLETED, AND IT WAS NOTED THE PATIENT EXPERIENCED RELIEF. LATER, THE PATIENT COMPLAINED OF SHORTNESS OF BREATH, DIFFICULTY BREATHING, AND NECK SWELLING. A REPEAT X-RAY SHOWED NO SIGNIFICANT INTERVAL CHANGE; HOWEVER, THERE WAS STILL SOME AIR-LEAK IN THE CHEST TUBE/PLEURAL VAC. THEN IT WAS DISCOVERED THAT THE STRAIGHTENING OBTURATOR WAS INADVERTENTLY LEFT IN THE CHEST TUBE. THE OBTURATOR WAS REMOVED, AND THE PATIENT'S SYMPTOMS IMPROVED. AS REPORTED THE PATIENT REQUIRED ADDITIONAL INTERVENTIONS/PROCEDURES. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.