BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

    MDR report key: 15729891 · Received November 4, 2022

    Report

    Report Number
    1820334-2022-01691
    Event Type
    Malfunction
    Date Received
    November 4, 2022
    Date of Event
    July 26, 2022
    Report Date
    November 3, 2022
    Manufacturer
    COOK INC
    Product Code
    MMX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510K= K181757. SUMMARY OF EVENT: AS INITIALLY REPORTED, DURING RETRIEVAL OF A COOK CELECT PLATINUM INFERIOR VENA CAVA FILTER THAT HAD BEEN IN PLACE FOR ONE YEAR, A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET'S SHEATH BUCKLED. THE SET WAS PLACED IN THE PATIENT AND THE SNARE WAS USED TO HOOK THE FILTER; HOWEVER, UPON ADVANCING THE INNER AND OUTER SHEATHS, THE OUTER SHEATH BUCKLED. THE FILTER AND RETRIEVAL SET WERE REMOVED THROUGH A 14 FRENCH SHEATH THAT WAS ALREADY IN THE PATIENT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. A VISUAL INSPECTION OF THE COMPLAINT DEVICE WAS ALSO CONDUCTED. THE RETRIEVAL LOOP SYSTEM, BLUE OUTER SHEATH, BLACK INNER SHEATH, 14 FRENCH CHECK-FLO INTRODUCER, AND A CELECT-PT FILTER WERE RETURNED FOR DEVICE EVALUATION. THE BLUE OUTER SHEATH WAS CURVED AND KINKED, AND THE HUB WAS PULLED OFF THE SHEATH. THE FILTER WAS STUCK INSIDE THE BLUE SHEATH AND THE FILTER HOOK HAD PENETRATED THE SHEATH. THE SHEATH WAS COMPRESSED FROM THE FILTER HOOK TO THE PROXIMAL END. THE BLUE SHEATH WAS CUT TO REMOVE THE FILTER AND THE FILTER HOOK WAS NOTED TO HAVE BEEN PULLED. THE FLARE ON THE BLUE SHEATH WAS DAMAGED AND NOT SMOOTH. A NEW HUB WAS MOUNTED TO THE BLUE SHEATH, AND EVEN WITH A REASONABLE AMOUNT OF FORCE, THE HUB WAS NOT ABLE TO BE PULLED OFF THE SHEATH. THE RETRIEVAL LOOP SYSTEM WAS CURVED AND KINKED, AND AN INDENTATION WAS NOTED IN THE TIP. THE BLACK INNER SHEATH WAS RETURNED WITHIN THE BLUE SHEATH AND WAS ALSO CURVED AND COMPRESSED NEAR THE FLARE OF THE BLUE SHEATH. THE TIP OF THE BLACK SHEATH HAD A MINOR INDENTATION. THE 14 FRENCH CHECK-FLO INTRODUCER WAS RETURNED WITH AN INDENTATION IN THE TIP. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. ONE NON-CONFORMANCE WAS NOTED ON THE LOT; HOWEVER, ALL AFFECTED PRODUCT WAS SCRAPPED AND NOT REPLACED. BECAUSE THE NON-CONFORMING PRODUCT WAS PROPERLY DISPOSITIONED BEFORE QC RELEASE, THERE IS EVIDENCE THAT THE DHR WAS FULLY EXECUTED. THERE HAVE BEEN NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THE PRODUCT IFU INSTRUCTS THE USER TO COMPLETELY COLLAPSE THE FILTER IN THE INNER SHEATH PRIOR TO ADVANCING THE OUTER SHEATH AND WARNS, ¿EXCESSIVE FORCE SHOULD NOT BE EXERTED TO RETRIEVE THE FILTER.¿ THE INFORMATION PROVIDED UPON REVIEW OF THE DMR, DHR, IFU, AND INVESTIGATION OF THE RETURNED DEVICE PROVIDES 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 ALTHOUGH THE EXACT CAUSE FOR THE FAILURE CANNOT BE DETERMINED, BECAUSE THE FILTER WAS STUCK INSIDE THE OUTER SHEATH, IT HAD NOT BEEN FULLY COLLAPSED WITHIN THE INNER BLACK SHEATH BEFORE THE BLUE SHEATH WAS ADVANCED, AS INSTRUCTED IN THE IFU. IF EXCESSIVE FORCE WAS USED DURING FILTER RETRIEVAL, THAT MAY HAVE LED TO COMPRESSION, HUB SEPARATION, AND FLARE DAMAGE FOUND UPON RETURN OF THE DEVICE. 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 · 0

    AS INITIALLY REPORTED, DURING RETRIEVAL OF A COOK CELECT PLATINUM INFERIOR VENA CAVA FILTER THAT HAD BEEN IN PLACE FOR ONE YEAR, A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET'S SHEATH BUCKLED. THE SET WAS PLACED IN THE PATIENT AND THE SNARE WAS USED TO HOOK THE FILTER; HOWEVER, UPON ADVANCING THE INNER AND OUTER SHEATHS, THE OUTER SHEATH BUCKLED. THE FILTER AND RETRIEVAL SET WERE REMOVED THROUGH A 14 FRENCH SHEATH THAT WAS ALREADY IN THE PATIENT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. UPON RETURN AND EVALUATION OF THE DEVICE, THE FILTER HAD NOT FULLY COLLAPSED WITHIN THE BLACK INNER SHEATH, AND THE FILTER HOOK HAD PENETRATED THE OUTER SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2788646 GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET MMX DEVICE, PERCUTANEOUS RETRIEVAL MMX COOK INC 14812908

    Patients

    Seq Age Sex Outcome Treatment
    1 Male