GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. CORRECTED INFORMATION: H6 (ANNEX A, G) SUMMARY OF EVENT: AS REPORTED, DURING ATTEMPTED RETRIEVAL OF AN UNKNOWN INFERIOR VENA CAVA FILTER, THE DISTAL PORTION OF A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET'S SHEATH BECAME STUCK AND "BOGGED UP". PER THE REPORTER, THE SHEATH "CRIPPLED" DOWN OVER THE SNARE. THE TUOHY-BORST VALVE WAS CUT OFF THE DEVICE AND THE USER REPORTEDLY CUT THE SHEATH IN ORDER TO REMOVE THE ENTIRE SYSTEM FROM THE PATIENT. THE FILTER WAS RETRIEVED AND THERE WAS NO HARM TO THE PATIENT, WHO RECOVERED FINE. A PHOTO PROVIDED BY THE CUSTOMER SHOWS STRETCHING, BUNCHING, AND TWISTING OF THE DISTAL INNER SHEATH, WITH THE SHEATH POSSIBLY OVERLAPPING THE RADIOPAQUE BAND. THE SNARE WIRE IS IN THE LUMEN OF THE SHEATH. THE INNER AND OUTER SHEATHS BOTH APPEAR TO HAVE BEEN CUT BELOW THE HUBS (THE CUSTOMER REPORTED THAT THE GTRS WAS CUT). INVESTIGATION EVALUATION: REVIEWS OF THE INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROLS WERE CONDUCTED DURING THE INVESTIGATION. A VISUAL INSPECTION OF THE PROVIDED PHOTOS WAS ALSO CONDUCTED. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION; HOWEVER, A PHOTO WAS PROVIDED BY THE CUSTOMER. THE PHOTO SHOWS THE BLUE RETRIEVAL SHEATH WITH THE LOOP WIRE INSIDE. AN UN-COLLAPSED FILTER IS ATTACHED TO THE LOOP. THE DISTAL PART OF THE SHEATH IS SEVERELY TWISTED/ROTATED. THE SHEATH HUB AND RADIOPAQUE BAND ARE NOT VISIBLE. THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER TO COOK; THEREFORE, IT IS UNKNOWN IF THERE WERE ANY NON-CONFORMANCES OR ADDITIONAL COMPLAINTS ON THE LOT, AS THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE REVIEWED. THE PRODUCT IFU INSTRUCTS THE USER HOW TO LOCK THE FILTER TO THE LOOP SYSTEM CATHETER AND ADVANCE THE BLACK RETRIEVAL CATHETER TO COLLAPSE THE FILTER BEFORE THE BLUE SHEATH IS ADVANCED TO COVER THE ENTIRE FILTER. THE INFORMATION PROVIDED UPON REVIEW OF THE DMR AND IFU 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. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT FAILURE TO FOLLOW INSTRUCTIONS LIKELY CONTRIBUTED TO THIS EVENT. THE LOOP SYSTEM CATHETER AND BLACK RETRIEVAL CATHETER WERE NOT VISIBLE ON THE PHOTO, AND THEREFORE WERE LIKELY NOT USED TO PROPERLY COLLAPSE THE FILTER FOR RETRIEVAL, CONSEQUENTLY LEADING TO USE OF STRONG MANIPULATION AND ROTATION DURING THE DIFFICULT RETRIEVAL, CAUSING DAMAGE TO THE SHEATH. THE IFU INSTRUCTS THE USER HOW TO LOCK THE FILTER TO THE LOOP SYSTEM CATHETER AND ADVANCE THE BLACK RETRIEVAL CATHETER TO COLLAPSE THE FILTER BEFORE THE BLUE SHEATH IS ADVANCED TO COVER THE ENTIRE FILTER. 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.

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

AS REPORTED, DURING ATTEMPTED RETRIEVAL OF AN UNKNOWN INFERIOR VENA CAVA FILTER, THE DISTAL PORTION OF A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET'S SHEATH BECAME STUCK AND "BOGGED UP". PER THE REPORTER, THE SHEATH "CRIPPLED" DOWN OVER THE SNARE. THE TUOHY-BORST VALVE WAS CUT OFF THE DEVICE AND THE USER REPORTEDLY CUT THE SHEATH IN ORDER TO REMOVE THE ENTIRE SYSTEM FROM THE PATIENT. THE FILTER WAS RETRIEVED AND THERE WAS NO HARM TO THE PATIENT, WHO RECOVERED FINE. A PHOTO PROVIDED BY THE CUSTOMER SHOWS STRETCHING, BUNCHING, AND TWISTING OF THE DISTAL INNER SHEATH, WITH THE SHEATH POSSIBLY OVERLAPPING THE RADIOPAQUE BAND. THE SNARE WIRE IS IN THE LUMEN OF THE SHEATH. THE INNER AND OUTER SHEATHS BOTH APPEAR TO HAVE BEEN CUT BELOW THE HUBS (THE CUSTOMER REPORTED THAT THE GTRS WAS CUT).

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. E3: OCCUPATION = LEAD TECH. G4: PMA/510(K) NUMBER = K181757. 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.