BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMER INTRODUCER

    MDR report key: 11027271 · Received December 17, 2020

    Report

    Report Number
    1820334-2020-02325
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Date of Event
    December 10, 2020
    Report Date
    June 11, 2021
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002106260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PMA/510(K) NUMBER: K171999. SUMMARY OF EVENT: AS REPORTED, PRIOR TO INSERTION DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION PROCEDURE, THE TIP OF A PERFORMER INTRODUCER WAS NOTED TO BE TORN. ACCESS WAS OBTAINED IN THE RIGHT FEMORAL ARTERY. AS THE USER ATTEMPTED TO INSERT THE COMPLAINT DEVICE OVER ANOTHER MANUFACTURER¿S 0.035-INCH WIRE GUIDE, A TEAR WAS FOUND AT THE TIP OF THE SHEATH. RESISTANCE WAS NOT REPORTED. THE DEVICE WAS NOT USED, AND ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. 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), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. A VISUAL INSPECTION OF THE COMPLAINT DEVICE WAS ALSO CONDUCTED. THE COMPLAINT DEVICE WAS RETURNED FOR INVESTIGATION WITH BIOMATTER PRESENT. THE DILATOR TIP WAS SPLIT AND PEELED BACK. 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. EVIDENCE FROM THE COMPLAINT FILE, DEVICE HISTORY RECORD, COMPLAINT HISTORY, MANUFACTURING DOCUMENTS, AND DEVICE FAILURE ANALYSIS SUGGESTS THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING DEVICES FROM THE COMPLAINT LOT IN HOUSE OR IN THE FIELD. THE PRODUCT IFU INSTRUCTS THE USER TO INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED UPON REMOVAL FROM THE PACKAGE. 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 COMPONENT FAILURE CONTRIBUTED TO THIS EVENT. 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

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    PMA/510K #: PREAMENDMENT. 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 · 1

    AS REPORTED, PRIOR TO INSERTION DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION PROCEDURE, THE TIP OF A PERFORMER INTRODUCER WAS NOTED TO BE TORN. ACCESS WAS OBTAINED IN THE RIGHT FEMORAL ARTERY. AS THE USER ATTEMPTED TO INSERT THE COMPLAINT DEVICE OVER ANOTHER MANUFACTURER¿S 0.035-INCH WIRE GUIDE, A TEAR WAS FOUND AT THE TIP OF THE SHEATH. RESISTANCE WAS NOT REPORTED. THE DEVICE WAS NOT USED, AND ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1491033 PERFORMER INTRODUCER DYB INTRODUCER, CATHETER DYB COOK INC G10626 13217542 00827002106260

    Patients

    Seq Age Sex Outcome Treatment
    1