GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

Additional Manufacturer Narrative

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

ADDITIONAL INFORMATION WAS RECEIVED 28DEC2021. THE PROCEDURE INVOLVED ATTEMPTED RETRIEVAL OF A COOK CELECT PLATINUM FILTER THAT HAD BEEN IN PLACE FOR OVER ONE YEAR. THE ANATOMY WAS NORMAL. THE FILTER WAS LAYING ON THE POSTERIOR CAVAL WALL AND WAS LIKELY ENDOTHELIALIZED. THE USER INADVERTENTLY CAPTURED A FEW OF THE SECONDARY FILTER LEGS IN THE SNARE, WHICH WAS CONFIRMED WITH IMAGING. THE USER WAS ABLE TO PUSH THE SNARE OFF THE LEGS, BUT IT WOULD NOT RELEASE. THE USER THEN PULLED THE SNARE UP OFF THE LEGS, WHICH WERE FLIPPED UPWARD, AND THE SNARE RELEASED THE LEGS OF THE FILTER. WHILE ATTEMPTING TO UNTANGLE THE SNARE FROM THE FILTER/LEGS, THE PIN VISE CAME OFF THE SNARE AND WAS UNABLE TO BE REPLACED. A SECOND SNARE WAS USED TO ATTEMPT RETRIEVAL FOR A FEW MINUTES; HOWEVER, THE USER DECIDED TO ABORT THE RETRIEVAL PROCEDURE AND REFER THE CASE OUT.

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. SUMMARY OF EVENT: AS REPORTED, DURING THE ATTEMPTED RETRIEVAL OF A COOK CELECT PLATINUM FILTER THAT HAD BEEN IN PLACE FOR OVER ONE YEAR, THE PIN VISE SEPARATED FROM A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET. THE FILTER WAS REPORTEDLY TILTED AND LAYING ON THE POSTERIOR CAVAL WALL AND WAS LIKELY ENDOTHELIALIZED/EMBEDDED IN THE CAVAL WALL. THE COMPLAINT DEVICE'S SNARE WAS ADVANCED OVER THREE SECONDARY FILTER STRUTS, INADVERTENTLY CAPTURING A FEW OF THE SECONDARY FILTER LEGS, WHICH WAS CONFIRMED WITH IMAGING. THE USER WAS ABLE TO PUSH THE SNARE OFF THE LEGS, BUT IT WOULD NOT RELEASE. THE USER THEN PULLED THE SNARE UP OFF THE LEGS, WHICH WERE FLIPPED UPWARD, AND THE SNARE RELEASED THE LEGS OF THE FILTER. WHILE ATTEMPTING TO UNTANGLE THE SNARE FROM THE FILTER/LEGS, EXCESSIVE PRESSURE WAS REPORTEDLY APPLIED, AND THE PIN VISE CAME OFF THE SNARE AND WAS UNABLE TO BE REPLACED. A SECOND SNARE WAS USED TO ATTEMPT RETRIEVAL FOR A FEW MINUTES; HOWEVER, THE USER DECIDED TO ABORT THE RETRIEVAL PROCEDURE. THE FILTER WAS NOT RETRIEVED FROM THE PATIENT. THE PATIENT WAS REFERRED TO ANOTHER FACILITY THAT SPECIALIZES IN DIFFICULT FILTER RETRIEVALS. INVESTIGATION EVALUATION: REVIEWS OF THE INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL PROCEDURES AND SPECIFICATIONS WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION. COOK WAS UNABLE TO CONDUCT A REVIEW OF THE DEVICE HISTORY RECORD, AS THE LOT NUMBER OF THE COMPLAINT DEVICE WAS NOT PROVIDED BY THE CUSTOMER. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THIS TYPE OF DEVICE WAS MANUFACTURED TO SPECIFICATIONS. SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE INSTRUCTIONS FOR USE (IFU) WARNS - "EXCESSIVE FORCE SHOULD NOT BE EXERTED TO RETRIEVE THE FILTER." THE INFORMATION PROVIDED UPON REVIEW OF THE DMR AND IFU SUGGESTS THAT THERE IS NO EVIDENCE THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. THERE IS NO EVIDENCE OF NON-CONFORMING DEVICES IN-HOUSE OR IN THE FIELD. COOK HAS CONCLUDED THAT THE EXACT REASON FOR DIFFICULTIES ENCOUNTERED WHEN ATTEMPTING TO RETRIEVE THE CELECT-PT FILTER CANNOT BE DETERMINED. HOWEVER, IT IS NOTED THAT ¿WHILE TRYING TO REMOVE THE SNARE, STRUTS STILL ENTANGLED, THE PHYSICIAN PUT TOO MUCH PRESSURE ON IT AND TWO OF THE SECONDARY STRUTS BENT UP INTO THE VENA CAVA.¿ THE INSTRUCTIONS FOR USE WARN THAT ¿EXCESSIVE FORCE SHOULD NOT BE EXERTED TO RETRIEVE THE FILTER.¿ THEREFORE, COOK HAS CONCLUDED THAT UNINTENDED USER ERROR CONTRIBUTED TO THE DEVICE FAILURE IN THIS COMPLAINT. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED AND NO ADDITIONAL ESCALATION WAS 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.

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

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.

Description of Event or Problem

AS REPORTED, DURING THE ATTEMPTED RETRIEVAL OF AN UNKNOWN INFERIOR VENA CAVA FILTER, THE PIN VISE SEPARATED FROM A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET. THE UNKNOWN FILTER WAS REPORTEDLY TILTED AND THE HOOK APPEARED TO BE EMBEDDED IN THE CAVAL WALL; THEREFORE, A DIFFICULT RETRIEVAL WAS ANTICIPATED. THE COMPLAINT DEVICE'S SNARE WAS ADVANCED OVER THREE SECONDARY FILTER STRUTS, WHICH BECAME STUCK. THE PHYSICIAN WAS UNABLE TO UNTANGLE THE FILTER STRUTS, AND IN THE PROCESS OF ATTEMPTING TO DO SO, THE PIN VISE SEPARATED FROM THE SNARE. THE USER REMOVED THE CATHETER AND REGAINED CONTROL OF THE SNARE. AS THE PHYSICIAN ATTEMPTED TO REMOVE THE SNARE FROM THE PATIENT, THE ENTANGLED FILTER STRUTS BENT UP INTO THE VENA CAVA WHEN EXCESS PRESSURE WAS APPLIED TO THE SNARE. THE FILTER WAS NOT RETRIEVED FROM THE PATIENT. THE PATIENT WAS REFERRED TO ANOTHER FACILITY THAT SPECIALIZES IN DIFFICULT FILTER RETRIEVALS. ADDITIONAL EVENT AND PATIENT OUTCOME INFORMATION HAS BEEN REQUESTED.