VENTRICLEAR DRAINAGE CATHETER SET

Description of Event or Problem

IT WAS REPORTED THAT THE CATHETER INCLUDED IN VENTRICLEAR DRAINAGE CATHETER SET BROKE DURING EXTERNAL VENTRICULAR DRAINAGE-DRESSING CHANGE PROCEDURE ON A FEMALE PATIENT OF UNKNOWN AGE. AS REPORTED BY THE NURSE, WHILE READJUSTING THE PATIENT¿S EXTERNAL VENTRICULAR DRAIN (EVD) CATHETER DRESSING, THE PORTION COVERING THE TUBING WAS COMPLETELY OFF. THE PATIENT EXPERIENCED A SHARP PAIN AS THE NURSE¿S HAND WAS ON THE DRESSING, PULLING FORCEFULLY AWAY FROM THE TUBING. THE CATHETER BROKE IN TO TWO PIECES: ONE REMAINED ATTACHED TO THE PATIENT AND THE OTHER FLOATED IN THE AIR. THE NURSE IMMEDIATELY CLAMPED THE TUBING AND CALLED THE PHYSICIAN FOR FURTHER ASSESSMENT. THE TUBING WAS REATTACHED WITHOUT COMPLICATION BY THE PHYSICIAN ASSISTANT (PA-C) AND WAVE FORMS WERE REASSESSED. THE PHYSICIAN¿S REPORT CONFIRMED THAT THE VENTRICULOSTOMY CATHETER BROKE APPROXIMATELY 2-3 CM FROM THE ORANGE CATHETER WHERE IT EXITS THE SCALP DURING A READJUSTMENT BY THE NURSE. THE PATIENT SCREAMED IN PAIN AND PULLED AWAY THE NURSE'S HAND, LEADING TO THE BREAKAGE. THE NURSE CLAMPED THE VENTRICULOSTOMY IMMEDIATELY AND THE PHYSICIAN WAS CALLED TO REINSERT THE TUBING. THEY HAD TO SHAVE PATIENT¿S HEAD A BIT MORE TO ACCESS AND ADEQUATELY SECURE THE TUBING. THE REMAINING STUMP OF THE CATHETER, ALONG WITH THE CONICAL HUB, WAS PREPPED WITH CHLORAPREP BEFORE REATTACHING THE COMPONENTS. TUBING WAS SECURED, AND WAVEFORMS RETURNED TO BASELINE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. E1-(CUSTOMER PERSON): (B)(6). 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

INVESTIGATION ¿ EVALUATION. IT WAS REPORTED THAT THE CATHETER FROM A VENTRICLEAR DRAINAGE CATHETER SET SEPARATED. THE DEVICE WAS PLACED FOR USE AS AN EXTERNAL VENTRICULAR DRAIN (EVD). LATER, WHEN THE NURSE WAS ATTEMPTING TO ADJUST THE CATHETER¿S DRESSING, THE PATIENT EXPERIENCED A SHARP PAIN. THE PATIENT FORCIBLY PULLED AWAY FROM THE NURSE HOLDING THE CATHETER, WHICH RESULTED IN CATHETER SEPARATION. THE NURSE IMMEDIATELY CLAMPED THE PORTION OF THE CATHETER STILL IN THE PATIENT'S HEAD AND CALLED THE PHYSICIAN FOR ASSESSMENT. THE PHYSICIAN¿S ASSISTANT (PA-C) SHAVED AN ADDITIONAL PORTION OF THE PATIENT¿S HEAD FOR ACCESS. THE PORTION OF THE CATHETER IN THE PATIENT AND THE ORANGE CONICAL HUB WERE BOTH CLEANSED WITH A CHLORHEXIDINE GLUCONATE AND ALCOHOL SOLUTION AND WERE THEN REATTACHED. THE CATHETER WAS SECURED, AND WAVEFORM RETURNED TO BASELINE. REVIEWS OF THE DOCUMENTATION INCLUDING QUALITY CONTROL PROCEDURES AND INSTRUCTIONS FOR USE (IFU) OF THE DEVICE WERE COMPLETED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A PHYSICAL EXAMINATION COULD NOT 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) COULD NOT BE COMPLETED DUE TO THE LACK OF LOT INFORMATION FROM THE FACILITY. A SALES SEARCH TO THE CUSTOMER WAS UNABLE TO IDENTIFY THE COMPLAINT LOT. COOK WAS ABLE TO REVIEW PRODUCT LABELING. THE USER FOLLOWED ALL RELEVANT INSTRUCTIONS IN THE IFU RELATED TO THIS FAILURE. EVIDENCE PROVIDED BY MANUFACTURING DOCUMENTS SUGGESTS THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING DEVICES IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, IT WAS CONCLUDED THAT AN UNINTENDED USER ERROR LED TO THE REPORTED FAILURE. AS REPORTED, THE CATHETER WAS ACCIDENTALLY PULLED ON BY THE PATIENT AND NURSE DURING A DRESSING CHECK. IT¿S POSSIBLE THIS CAUSED THE CATHETER TO SEPARATE. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. 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.

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

CORRECTION: E1: THIS REPORT WAS FORWARDED TO COOK INCORPORATED FROM MEDTRONIC. THE EVENT WAS REPORTED TO MEDTRONIC BY (B)(6) MSN, RN, CAPA, CLINICAL QUALITY VALUE ANALYSIS COORDINATOR, (B)(6) HEALTH. OFFICE (B)(6). CQVA/PATIENT CARE AREAS: (B)(6), (B)(6) HOSPITALS, (B)(6). (B)(6) MEDICAL CENTER (B)(6). 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

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