GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

Description of Event or Problem

AS REPORTED, DURING A FILTER RETRIEVAL PROCEDURE, A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET¿S WIRE UNRAVELED WHILE OBTAINING ACCESS IN THE INTERNAL JUGULAR VEIN. ACCESS WAS REPORTEDLY DIFFICULT, AS THE VEIN/ACCESS SITE HAD BEEN USED FOR PREVIOUS INTERVENTIONS. THE USER CONTINUED TO USE THE WIRE, DESPITE IT UNRAVELING. THE UNKNOWN FILTER WAS SUCCESSFULLY RETRIEVED AS INTENDED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. 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 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.

Additional Manufacturer Narrative

SUMMARY OF EVENT: AS REPORTED, DURING A FILTER RETRIEVAL PROCEDURE, A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET¿S WIRE UNRAVELED WHILE OBTAINING ACCESS IN THE INTERNAL JUGULAR VEIN. ACCESS WAS REPORTEDLY DIFFICULT, AS THE VEIN/ACCESS SITE HAD BEEN USED FOR PREVIOUS INTERVENTIONS. THE USER CONTINUED TO USE THE WIRE, DESPITE IT UNRAVELING. THE UNKNOWN FILTER WAS SUCCESSFULLY RETRIEVED AS INTENDED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. A VISUAL INSPECTION OF THE COMPLAINT DEVICE WAS ALSO CONDUCTED. THE COMPLAINT DEVICE WAS RETURNED TO COOK FOR INVESTIGATION. THE WIRE WAS UNRAVELED AT THE DISTAL END. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO RELEVANT NON-CONFORMANCES ON THE LOT. A REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL COMPLAINTS FOR THIS LOT NUMBER. THE PRODUCT IFU INSTRUCTS THE USER TO ACCESS THE CHOSEN JUGULAR VEIN USING THE SELDINGER TECHNIQUE AND DILATE THE PUNCTURE SITE, IF NECESSARY. 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 INFORMATION PROVIDED UPON REVIEW OF THE DMR, DHR, IFU, AND INVESTIGATION OF THE RETURNED DEVICE SUGGESTS THAT THERE IS EVIDENCE THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NON-CONFORMING DEVICES IN-HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT THE PATIENT¿S ANATOMY AND FAILURE TO FOLLOW INSTRUCTIONS CONTRIBUTED TO THIS EVENT, AS THE WIRE WAS ADVANCED THROUGH THE DIFFICULT ACCESS SITE. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED AND NO ADDITIONAL ESCALATION WAS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED, AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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.