BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION BYRD POLYPROPYLENE EXTRA LONG DILATOR SHEATH SET

    MDR report key: 11215081 · Received January 22, 2021

    Report

    Report Number
    2522007-2021-00002
    Event Type
    Injury
    Date Received
    January 22, 2021
    Date of Event
    August 30, 2014
    Report Date
    August 30, 2021
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    GCC
    PMA / PMN Number
    K893480
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D2: COMMON NAME: DILATOR, CATHETER. D2B: PRODUCT CODE: GCC. G5: PMA/510(K): K893480. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE OR UPON COMPLETION OF INVESTIGATION. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR 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

    THIS LITERATURE FINDING SPECIFIES 1 MAJOR ADVERSE EVENT ATTRIBUTED TO THE INTEROPERATIVE FRACTURE OF A COOK POLYPROPYLENE BYRD DILATOR SHEATH (LR-PPLBES-13.0-XL) DURING A LEAD EXTRACTION PROCEDURE IN 2014. THE PUBLISHED LITERATURE IS REFERRING TO A KNOWN TIME WHEN THE CUSTOMER IN POLAND HAD THE PRACTICE OF ¿RE-STERILIZING¿ THE BYRD DILATOR SHEATHS AND USING ONLY ONE OF THE RE-STERILIZED TELESCOPING INNER AND OUTER SHEATHS FOR THE EXTRACTION OF THE IMPLANTED LEAD. ALTHOUGH STERILIZATION OF THE DEVICE DEFIES THE MANUFACTURES INSTRUCTIONS FOR USE, THE PRACTICE OF USING ONLY ONE INSTEAD OF BOTH THE INNER AND OUTER SHEATH TOGETHER MEANT THAT THE INTEGRITY OF THE DEVICES WERE COMPROMISED. THIS PRACTICE CONTINUED UNTIL THE CUSTOMER WAS FINALLY QUESTIONED BY ANOTHER PHYSICIAN FROM ANOTHER COUNTRY ABOUT THIS VERY POOR PRACTICE AT A CONFERENCE. TO COOK¿S KNOWLEDGE, THE CUSTOMER NO LONGER PRACTICES ¿RE-STERILIZING¿ OF THE BYRD SHEATHS AND THEY HAVE IN FACT CHANGED TO USING THE COOK EVOLUTION RL DEVICES WITHOUT INCIDENT.

    Additional Manufacturer Narrative · 1

    COMMON NAME: DILATOR, CATHETER. PRODUCT CODE: GCC. PMA/510(K): K893480. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE OR UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    THIS LITERATURE FINDING SPECIFIES 1 MAJOR ADVERSE EVENT ATTRIBUTED TO THE INTEROPERATIVE FRACTURE OF A COOK POLYPROPYLENE BYRD DILATOR SHEATH (LR-PPLBES-13.0-XL) DURING A LEAD EXTRACTION PROCEDURE IN 2014. THE PUBLISHED LITERATURE IS REFERRING TO A KNOWN TIME WHEN THE CUSTOMER IN (B)(6) HAD THE PRACTICE OF ¿RE-STERILIZING¿ THE BYRD DILATOR SHEATHS AND USING ONLY ONE OF THE RE-STERILIZED TELESCOPING INNER AND OUTER SHEATHS FOR THE EXTRACTION OF THE IMPLANTED LEAD. ALTHOUGH STERILIZATION OF THE DEVICE DEFIES THE MANUFACTURES INSTRUCTIONS FOR USE, THE PRACTICE OF USING ONLY ONE INSTEAD OF BOTH THE INNER AND OUTER SHEATH TOGETHER MEANT THAT THE INTEGRITY OF THE DEVICES WERE COMPROMISED. THIS PRACTICE CONTINUED UNTIL THE CUSTOMER WAS FINALLY QUESTIONED BY ANOTHER PHYSICIAN FROM ANOTHER COUNTRY ABOUT THIS VERY POOR PRACTICE AT A CONFERENCE. TO COOK¿S KNOWLEDGE, THE CUSTOMER NO LONGER PRACTICES ¿RE-STERILIZING¿ OF THE BYRD SHEATHS AND THEY HAVE IN FACT CHANGED TO USING THE COOK EVOLUTION RL DEVICES WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109079 LEAD EXTRACTION BYRD POLYPROPYLENE EXTRA LONG DILATOR SHEATH SET GCC COOK VANDERGRIFT INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention