BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 10535575 · Received September 15, 2020

    Report

    Report Number
    1820334-2020-01689
    Event Type
    Malfunction
    Date Received
    September 15, 2020
    Date of Event
    July 27, 2020
    Report Date
    October 14, 2020
    Manufacturer
    COOK INC
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: UPON FURTHER INVESTIGATION OF THE RETURNED SHEATH, THE DEVICE WAS NOT SEPARATED AS ORIGINALLY REPORTED. THE TIP OF THE DEVICE WAS DAMAGED; HOWEVER, NO SPLIT, FRAY, OR SHARP EDGE WAS NOTED. THERE IS NO EVIDENCE TO SUGGEST THAT THIS 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 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

    UPON FURTHER INVESTIGATION, THE DEVICE WAS NOT SEPARATED.

    Additional Manufacturer Narrative · 1

    OCCUPATION = LAB MANAGER. PMA/510(K) NUMBER = ALTHOUGH THE SPECIFIC RPN IS UNKNOWN, THE 510(K) FOR FLEXOR SHEATHS IS EITHER K142829, K142819, OR K153430. 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

    UPON RETURN OF THE DEVICE ASSOCIATED WITH A PREVIOUSLY REPORTED COMPLAINT, REPORTED UNDER MDR REFERENCE NUMBER 1820334-2020-01464, AN UNSPECIFIED 6 FRENCH COOK FLEXOR SHEATH WAS ALSO RETURNED AND WAS NOTED TO BE SEPARATED. THE PROCEDURE WAS AN INTERVENTION OF THE LEFT COMMON ILIAC ARTERY VIA LEFT COMMON FEMORAL ACCESS. THE ANATOMY WAS HIGHLY CALCIFIED. DURING THE PROCEDURE, THE COOK BALLOON ASSOCIATED WITH REPORT 1820334-2020-01464 BECAME STUCK ON THE STENT AFTER STENT PLACEMENT, AS THE BALLOON WAS REMOVED. THE BALLOON WAS ADVANCED INTO THE AORTA AND INFLATED AND DEFLATED "A COUPLE TIMES" AND WAS THEN REMOVED. NO MALFUNCTION OF THE SHEATH WAS REPORTED BY THE USER FACILITY. 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
    1000061 UNKNOWN DYB INTRODUCER, CATHETER DYB COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR FORB4-18-135-8-30, HYDRO ST WIRE| FORB4-18-135-8-30, HYDRO ST WIRE.