BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMER MULLINS GUIDING SHEATH

    MDR report key: 18576056 · Received January 24, 2024

    Report

    Report Number
    1820334-2024-00120
    Event Type
    Malfunction
    Date Received
    January 24, 2024
    Date of Event
    January 5, 2024
    Report Date
    May 14, 2024
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002091092
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B1, H1: ADDITIONAL INFORMATION RECEIVED ON 16APR2024 CONFIRMED THAT THE DILATORS WERE NOT CRACKED AS ORIGINALLY REPORTED, BUT THE SHEATH TIPS WERE DEFORMED. THIS IS CONSISTENT WITH THE CONDITION OF THE RETURNED DEVICES. PER A SEARCH OF RISK DOCUMENTATION AND PREVIOUS COMPLAINT DATA, THERE IS NO EVIDENCE TO SUGGEST THAT SHEATH TIP DEFORMATION WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR A SERIOUS INJURY IF THE FAILURE 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.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. E1: (B)(6). G4: PMA/510(K) NUMBER = K171988. 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED 16APR2024. THE DILATORS WERE NOT CRACKED AS ORIGINALLY REPORTED; HOWEVER, THE SHEATH TIPS WERE DEFORMED, DESCRIBED AS "WAVING/FLARING".

    Description of Event or Problem · 0

    AS ORIGINALLY REPORTED, THE TIPS OF THREE PERFORMER MULLINS GUIDING SHEATH¿S DILATORS WERE FOUND TO BE ¿CRACKED VERTICALLY¿ UPON OPENING THE PACKAGES. ONE OF THE DEVICES ¿WITH RELATIVELY FEW CRACKS¿ WAS USED, DESPITE THE CRACK(S) BEING NOTED PRIOR TO USE. ADDITIONAL INFORMATION WAS RECEIVED, STATING THAT THE CRACKS WERE NOT OBSERVED UPON OPENING THE PACKAGE, BUT RATHER THAT THE PATIENT FELT DISCOMFORT UPON INSERTION OF THE DEVICE, AND UPON CHECKING, THE DILATOR AND SHEATH HAD CRACKS AND ¿ROLL-UP¿. DAMAGE TO THE SHEATH WAS THOUGHT TO BE CAUSED BY ¿STRONG THRUSTING¿, AND PER THE REPORTER, RESISTANCE WAS LIKELY ENCOUNTERED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. 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
    1056722 PERFORMER MULLINS GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK INC 15576624 00827002091092

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown