BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMER INTRODUCER

    MDR report key: 14435869 · Received May 19, 2022

    Report

    Report Number
    1820334-2022-00739
    Event Type
    Malfunction
    Date Received
    May 19, 2022
    Date of Event
    May 10, 2022
    Report Date
    August 24, 2022
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002283220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). PMA/510(K) NUMBER = K171999. 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, DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION PROCEDURE, A PERFORMER INTRODUCER LEAKED FROM THE SIDE PORT AFTER THE DEVICE WAS INSERTED. THE INTRODUCER WAS REMOVED AND REPLACED WITH ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT, WHO HAS RECOVERED. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. A VISUAL INSPECTION AND FUNCTIONAL TEST OF THE COMPLAINT DEVICE WAS ALSO CONDUCTED. THE 16 FRENCH PERFORMER INTRODUCER AND A 16 FRENCH DILATOR WERE RETURNED TO COOK FOR INVESTIGATION. THE INTRODUCER LEAKED FROM THE SILICONE DISC AREA ON THE PROXIMAL HUB. THE HUB WAS DISMANTLED, AND EXAMINATION OF THE DISC REVEALED DAMAGE TO THE EXTERIOR OF THE SILICONE DISC ON THE SIDE FACING THE USER. THE DISC WAS ALSO NOT SLIT PROPERLY TO ENSURE A LEAK-FREE SEAL. 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 CAUTIONS: ¿ALL INSTRUMENTS OR CATHETERS USED WITH THIS PRODUCT SHOULD MOVE FREELY THROUGH THE VALVE AND SHEATH. DAMAGE TO THE VALVE/INTRODUCER MAY RESULT WHEN THE FIT IS TIGHT.¿ THE INFORMATION PROVIDED UPON REVIEW OF THE DMR, DHR, IFU, AND INVESTIGATION OF THE RETURNED DEVICE SUGGESTS THAT THERE IS EVIDENCE THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION; HOWEVER, BECAUSE THERE WERE NO RELATED NON-CONFORMANCES OR ADDITIONAL COMPLAINTS ON THE LOT, THERE IS NO EVIDENCE OF ADDITIONAL NON-CONFORMING DEVICES IN-HOUSE OR IN THE FIELD. AT THIS TIME, COOK BELIEVES THIS TO BE AN ISOLATED EVENT. 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 A MANUFACTURING/QUALITY DEFICIENCY CONTRIBUTED TO THIS EVENT. THE DISC MAY HAVE BEEN DAMAGED BY THE USER WHILE INSERTING THE DILATOR THROUGH THE HUB; HOWEVER, DURING THE INVESTIGATION, IT WAS DISCOVERED THAT THE DISC WAS NOT SLIT PROPERLY TO ENSURE A LEAK-FREE SEAL AS INTENDED. 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, DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION PROCEDURE, A PERFORMER INTRODUCER LEAKED FROM THE SIDE PORT AFTER THE DEVICE WAS INSERTED. THE INTRODUCER WAS REMOVED AND REPLACED WITH ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT, WHO HAS RECOVERED.

    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
    392339 PERFORMER INTRODUCER DYB INTRODUCER, CATHETER DYB COOK INC G28322 14172443 00827002283220

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown