SIMPLE PNEUMOTHORAX ASPIRATION ACCESSORY SET

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D4 - CATALOG # 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.

Additional Manufacturer Narrative

B3 ¿ DATE OF EVENT: EVENT OCCURRED SOMETIME IN 2018 E1 - CUSTOMER (PERSON): (B)(6). G4 ¿ PMA/510(K) #: EXEMPT. H3 - DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN. 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.

Description of Event or Problem

IT WAS REPORTED THAT THE COOK CHEST DRAIN VALVE INCLUDED IN A SIMPLE PNEUMOTHORAX ASPIRATION ACCESSORY SET WAS INADVERTENTLY REVERSED BY THE USER. THE FOLLOWING WAS PRESENTED VIA POSTER PRESENTATION AT THE SOCIETY FOR ACUTE MEDICINE - SPRING 2018 CONFERENCE, "COMPLICATING THE COMPLICATION - IATROGENIC PNEUMOTHORAX WORSENED BY INADVERTENT REVERSAL OF A HEIMLICH VALVE" BY (B)(6). A 73¿YEAR¿OLD FEMALE WITH A 40¿PACK¿YEAR SMOKING HISTORY UNDERWENT AN ELECTIVE COMPUTED TOMOGRAPHY GUIDED LUNG BIOPSY, WHICH WAS COMPLICATED BY A MODERATE RIGHT-SIDED PNEUMOTHORAX. THIS WAS TREATED BY TUBE THORACOSTOMY WITH AN AMBULATORY DRAIN (FROM ANOTHER MANUFACTURER) AND COOK CHEST DRAIN VALVE, WITH GOOD RADIOLOGIC EFFECT. THE FOLLOWING DAY, CHEST RADIOGRAPHY SHOWED UNEXPECTED EXTENSIVE SUBCUTANEOUS EMPHYSEMA WITH AN INCREASE IN PNEUMOTHORAX SIZE. INSPECTION OF THE DRAINAGE SYSTEM REVEALED REVERSAL OF THE CHEST DRAIN VALVE DIRECTION. AFTER THIS WAS CORRECTLY REPOSITIONED, THE RADIOGRAPHIC FINDINGS IMPROVED. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

Description of Event or Problem

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

Additional Manufacturer Narrative

INVESTIGATION ¿ EVALUATION: IT WAS REPORTED THAT THE COOK CHEST DRAIN VALVE INCLUDED IN A SIMPLE PNEUMOTHORAX ASPIRATION ACCESSORY SET (RPN AND LOT# UNKNOWN) WAS INADVERTENTLY REVERSED BY THE USER. THE FOLLOWING WAS PRESENTED VIA POSTER PRESENTATION AT THE SOCIETY FOR ACUTE MEDICINE - SPRING 2018 CONFERENCE, "COMPLICATING THE COMPLICATION - IATROGENIC PNEUMOTHORAX WORSENED BY INADVERTENT REVERSAL OF A HEIMLICH VALVE" BY EAMON MCCARRON, JASON WIEBOLDT, SHAAHID VALLEY, GLEN CLARKE, AND SHIVA SREENIVASAN. A 73¿YEAR¿OLD FEMALE WITH A 40¿PACK¿YEAR SMOKING HISTORY UNDERWENT AN ELECTIVE COMPUTED TOMOGRAPHY GUIDED LUNG BIOPSY, WHICH WAS COMPLICATED BY A MODERATE RIGHT-SIDED PNEUMOTHORAX. THIS WAS TREATED BY TUBE THORACOSTOMY WITH A COMPETITOR'S AMBULATORY DRAIN AND COOK CHEST DRAIN VALVE, WITH GOOD RADIOLOGIC EFFECT. THE FOLLOWING DAY, CHEST RADIOGRAPHY SHOWED UNEXPECTED EXTENSIVE SUBCUTANEOUS EMPHYSEMA WITH AN INCREASE IN PNEUMOTHORAX SIZE. INSPECTION OF THE DRAINAGE SYSTEM REVEALED REVERSAL OF THE CHEST DRAIN VALVE DIRECTION. AFTER THIS WAS CORRECTLY REPOSITIONED, THE RADIOGRAPHIC FINDINGS IMPROVED. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. REVIEWS OF DOCUMENTATION INCLUDING QUALITY CONTROL PROCEDURES, SPECIFICATIONS, AND MANUFACTURING INSTRUCTIONS (MI), FOR THE DEVICE 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. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE COMPLETED DUE TO A LACK OF LOT INFORMATION. AN EXPANDED SALES SEARCH FOR THIS CUSTOMER WAS UNABLE TO IDENTIFY THE COMPLAINT 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 THE FIELD. THERE ARE NO INSTRUCTIONS FOR USE (IFU) FOR THIS DEVICE. HOWEVER, THERE IS AN ARROW ON THE ONE-WAY VALVE COMPONENT INDICATING IN WHICH DIRECTION THE AIR FLOWS. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT, AND THE RESULTS OF THE INVESTIGATION, COOK CONCLUDES THIS EVENT TO BE DUE TO UNINTENDED USER ERROR. IT WAS REPORTED THAT THE DEVICE WAS INADVERTENTLY PLACED BACKWARDS BY THE USER. THE DEVICE DOES COME WITH LABELING ATTACHED TO THE CHEST DRAIN VALVE AND HAS AN ARROW ON THE DEVICE ITSELF INDICATING DIRECTION OF FLOW. 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, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.