BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR ANSEL GUIDING SHEATH

    MDR report key: 9793013 · Received March 5, 2020

    Report

    Report Number
    1820334-2020-00553
    Event Type
    Malfunction
    Date Received
    March 5, 2020
    Date of Event
    February 26, 2020
    Report Date
    March 5, 2020
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002481923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. B1, H1: ON RETURN OF DEVICE (B)(6) 2020, THE SHEATH APPEARED UNUSED. THE PLASTIC PROTECTOR TUBE WAS CRACKED IN MULTIPLE PLACES WITHIN A 6CM SECTION OF THE PROXIMAL END. THE DISTAL TIP OF THIS PROTECTOR WAS ALSO DAMAGED. THE SHEATH ITSELF WAS SMASHED AT 2MM FROM THE CHECK-FLO CAP, BUT NO CRACKS, FRACTURES, OR OTHER DAMAGE WAS NOTED TO THE DEVICE. THERE IS NO EVIDENCE TO SUGGEST THAT THE OBSERVED DEVICE FAILURE 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 TOOK PLACE, 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 · 1

    OCCUPATION = UNKNOWN. PMA/510(K) NUMBER = K142829. 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 AN UNKNOWN PROCEDURE, THE PLASTIC TUBING OF A FLEXOR ANSEL GUIDING SHEATH WAS FOUND TO BE CRACKED AND THE SHEATH APPEARED CRIMPED. THE PROCEDURE WAS INSTEAD COMPLETED WITH A COOK 6 FRENCH, 90 CENTIMETER ANSEL SHEATH. THE COMPLAINT DEVICE DID NOT MAKE PATIENT CONTACT. THE DEVICE WAS STORED HANGING ON A RACK IN THE PROCEDURE ROOM. THERE WAS NO DAMAGE TO THE PACKAGE NOTED. THERE HAVE BEEN NO REPORTED ADVERSE EFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255540 FLEXOR ANSEL GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK INC G48192 9328851 00827002481923

    Patients

    Seq Age Sex Outcome Treatment
    1