GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

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

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. CORRECTION: D4, H6 ANNEX A AND G SUMMARY OF EVENT: AS REPORTED, DURING RETRIEVAL OF ANOTHER MANUFACTURER'S INFERIOR VENA CAVA FILTER, A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET'S SHEATH AND SNARE CATHETER SPLIT AT THE TIPS. ACCESS WAS OBTAINED IN THE JUGULAR VEIN. REPORTEDLY, SOME OF THE FILTER STRUTS APPEARED TO HAVE PERFORATED THROUGH THE CAVAL WALL. THE FILTER WAS VERY DIFFICULT TO COLLAPSE INTO THE SHEATH; THEREFORE A "LOT" OF FORCE WAS APPLIED. THE TIP OF THE SHEATH SPLIT UPON COLLAPSING THE FILTER, AND THE SHEATH HUB BROKE OFF. THE TIP OF THE SNARE CATHETER ALSO SPLIT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK; HOWEVER, PHOTOS WERE PROVIDED BY THE CUSTOMER. THE PHOTOS SHOWED A SPLIT IN THE TIP OF THE BLUE RETRIEVAL SHEATH AND A SEVERE DENT IN THE DISTAL TIP OF THE BLACK RETRIEVAL CATHETER. THE RETRIEVAL LOOP APPEARED TO BE FRACTURED; HOWEVER, IT WAS REPORTED THAT THE LOOP WAS CUT BY THE USER IN ORDER TO REMOVE THE FILTER, AFTER IT WAS RETRIEVED FROM THE PATIENT. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. NO RELATED NON-CONFORMANCES WERE FOUND, AND THERE HAVE BEEN NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THE PRODUCT IFU SPECIFIES THAT THE GTRS IS INTENDED FOR RETRIEVAL OF COOK FILTERS AND WARNS THAT EXCESSIVE FORCE SHOULD NOT BE EXERTED TO RETRIEVE THE FILTER. 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 COMPLAINT FILE 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, THE COMPONENTS WERE EXPOSED TO MANIPULATION BEYOND THEIR INTENDED DESIGN AND ¿A LOT OF FORCE¿ WAS REPORTEDLY USED TO COLLAPSE AND RETRIEVE THE FILTER. THEREFORE, COOK HAS CONCLUDED THAT THE CAUSE OF THE EVENT CAN BE ATTRIBUTED TO CONTRADICTORY/UNAPPROVED/OFF-LABEL USE. 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.

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. G4: PMA/510(K) NUMBER = K222254. 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.

Description of Event or Problem

AS REPORTED, DURING RETRIEVAL OF ANOTHER MANUFACTURER'S INFERIOR VENA CAVA FILTER, A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET'S SHEATH AND SNARE CATHETER SPLIT AT THE TIPS. ACCESS WAS OBTAINED IN THE JUGULAR VEIN. REPORTEDLY, SOME OF THE FILTER STRUTS APPEARED TO HAVE PERFORATED THROUGH THE CAVAL WALL. THE FILTER WAS VERY DIFFICULT TO COLLAPSE INTO THE SHEATH; THEREFORE A "LOT" OF FORCE WAS APPLIED. THE TIP OF THE SHEATH SPLIT UPON COLLAPSING THE FILTER, AND THE SHEATH HUB BROKE OFF. THE TIP OF THE SNARE CATHETER ALSO SPLIT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.