BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMER INTRODUCER

    MDR report key: 20195265 · Received September 11, 2024

    Report

    Report Number
    1820334-2024-01210
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Date of Event
    August 15, 2024
    Report Date
    December 9, 2024
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E1: NAME AND ADDRESS - (B)(6). G4: PMA/510(K) NUMBER = K171609. 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

    CORRECTED INFORMATION: B1, H1, H6 (ANNEX A): UPON FURTHER REVIEW OF THE PROVIDED PHOTOS AND DISCUSSIONS WITH COOK MANUFACTURING QUALITY ENGINEERING, THE DISCOLORATION IS CONSIDERED ACCEPTABLE AND CONFORMING. THE DILATOR CONTAINS BISMUTH WHICH CAN DISCOLOR FROM UV LIGHT. IT DOES NOT HURT THE MECHANICAL PROPERTIES OF THE POLYMER. PER A SEARCH OF RISK DOCUMENTATION AND PREVIOUS COMPLAINT DATA, THERE IS NO EVIDENCE TO SUGGEST THAT THIS DISCOLORATION WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR A SERIOUS INJURY IF IT WERE TO RECUR. FURTHERMORE, THERE IS NO EVIDENCE THAT THE DEVICE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY, AS NO LIFE-THREATENING OR PERMANENTLY IMPAIRING INJURY WAS ALLEGED, NOR WAS INTERVENTION TAKEN AS A RESULT OF THE DEVICE FAILURE WHICH WOULD BE REQUIRED TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE TO THE PATIENT. AS SUCH, THE EVENT IS NOT REPORTABLE UNDER FDA 21 CFR PART 803 AS IT DOES NOT MEET THE CRITERIA FOR A DEATH, SERIOUS INJURY, OR REPORTABLE PRODUCT MALFUNCTION. 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 DURING A CORONARY ANGIOGRAM UNDER LOCAL ANESTHESIA, "STAINS" WERE NOTED ON THE SURFACE OF A PERFORMER INTRODUCER. AFTER OBTAINING ACCESS SUCCESSFULLY, THE USER OPENED THE PACKAGE OF THE COMPLAINT DEVICE; HOWEVER, WHILE CHECKING THE SHEATH, "STAINS" WERE NOTED ON THE SURFACE. THE SHEATH WAS NOT USED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. ALTHOUGH THE PROCEDURE WAS REPORTEDLY DELAYED, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. PHOTOS PROVIDED BY THE CUSTOMER SHOW THE DILATOR, NOT THE SHEATH AS REPORTED.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1474418 PERFORMER INTRODUCER DYB INTRODUCER, CATHETER DYB COOK INC G10270 15945838 00827002102705

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female