BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

    MDR report key: 14595939 · Received June 3, 2022

    Report

    Report Number
    1820334-2022-01001
    Event Type
    Malfunction
    Date Received
    June 3, 2022
    Report Date
    August 31, 2022
    Manufacturer
    COOK INC
    Product Code
    MMX
    UDI-DI
    10827002132877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) NUMBER = K181757. DEVICE EVALUATION HAS BEGUN; HOWEVER, A CONCLUSION IS NOT YET AVAILABLE. 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 · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. SUMMARY OF EVENT: AS REPORTED, PRIOR TO USE WHILE PREPPING FOR A PROCEDURE INVOLVING RETRIEVAL OF AN UNKNOWN INFERIOR VENA CAVA FILTER, THE COATING CAME OFF OF A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET'S DILATOR. THE PINK DILATOR WAS INSERTED INTO THE INNER SHEATH; HOWEVER, THE DILATOR WAS STICKY. AS THE DILATOR WAS PULLED OUT, THE USER NOTED THAT SOME OF THE COATING HAD COME OFF. THE DEVICE DID NOT MAKE PATIENT CONTACT. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, AND DOCUMENTATION WERE CONDUCTED DURING THE INVESTIGATION. A VISUAL INSPECTION OF THE COMPLAINT DEVICE WAS ALSO CONDUCTED. THE INTRODUCER DILATOR WAS RETURNED FOR DEVICE EVALUATION. NO BLOOD OR BIOLOGICAL MATTER WAS OBSERVED ON THE DILATOR. THE DILATOR WAS CURVED DUE TO SHIPMENT AND A KINK WAS OBSERVED; HOWEVER, SCRATCH MARKS WERE NOT OBSERVED. AN INNER SHEATH FROM A TEST DEVICE WAS USED TO TEST IF THE INTRODUCER DILATOR COULD BE ADVANCED THROUGH THE INNER SHEATH. IT WAS POSSIBLE TO ADVANCE THE INTRODUCER DILATOR THROUGH THE INNER SHEATH AND NO RESISTANCE WAS NOTED. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. ONE OTHER COMPLAINT WAS NOTED ON THE LOT; HOWEVER, THE COMPLAINT WAS NOT RELATED TO THIS FAILURE MODE. ONE NON-CONFORMANCE WAS NOTED; HOWEVER, ALL AFFECTED PRODUCT WAS SCRAPPED AND NOT REPLACED. BECAUSE THE DISCOVERED NON-CONFORMANCE WAS DISCOVERED AND PROPERLY DISPOSITIONED BEFORE QC RELEASE, THERE IS EVIDENCE THAT THE DHR WAS FULLY EXECUTED. IT IS THEREFORE CONCLUDED THAT THERE IS EVIDENCE THE COMPLAINT DEVICE WAS MANUFACTURED TO SPECIFICATION, AND THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN-HOUSE OR IN THE FIELD. THE PRODUCT IFU INSTRUCTS THE USER TO FLUSH THE PRE-DILATOR, COAXIAL RETRIEVAL SHEATH SYSTEM, AND RETRIEVAL LOOP SYSTEM DURING PREPARATION OF THE DEVICE. 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 A CAUSE FOR THIS EVENT CANNOT BE DETERMINED. 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 REPORTED, PRIOR TO USE WHILE PREPPING FOR A PROCEDURE INVOLVING RETRIEVAL OF AN UNKNOWN INFERIOR VENA CAVA FILTER, THE COATING CAME OFF OF A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET'S DILATOR. THE PINK DILATOR WAS INSERTED INTO THE INNER SHEATH; HOWEVER, THE DILATOR WAS STICKY. AS THE DILATOR WAS PULLED OUT, THE USER NOTED THAT SOME OF THE COATING HAD COME OFF. THE DEVICE DID NOT MAKE PATIENT CONTACT. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032630 GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET MMX DEVICE, PERCUTANEOUS RETRIEVAL MMX COOK INC 14523038 10827002132877

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown