BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATIN

    MDR report key: 1933471 · Received December 20, 2010

    Report

    Report Number
    2024168-2010-02833
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 25, 2010
    Manufacturer
    AV-BARCELONETA
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4): AGAINST RESISTANCE. STENT: ENDEAVOUR SPRINT; GOOSENECK SNARE. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). GUIDE WIRE TIP SEPARATION OF THIS NATURE CAN OCCUR, BUT IS NOT LIMITED TO WHEN THE CORE IS SUBJECTED TO TENSILE OR TORSIONAL LOADS BEYOND THE DESIGN LIMITS CAUSING THE TIP TO DETACH. TYPICALLY, THE FRACTURE SITE MORPHOLOGY SHOWS THE CORE WAS EXPOSED TO FORCES CONSISTENT WITH THOSE APPLIED THROUGH PULLING, TORQUING AND/OR MANIPULATION. A WIRE BEING OVER PULLED OR OVER TORQUED WOULD REQUIRE THE TIP TO BE TRAPPED. NO DAMAGE TO THE GUIDE WIRE WAS REPORTED PRIOR TO USE, WHICH SUGGESTS THAT THE DAMAGE WAS LIKELY NOT PRE-EXISTING. THE GUIDE WIRE WAS NOT RETURNED, WHICH MAY HAVE AIDED IN THE EVALUATION. PATIENT ANATOMY, LESION MORPHOLOGY, AND/OR RESISTANCE BETWEEN THE PRODUCTS CAN ALL BE FACTORS. ANY ATTEMPTS TO MOVE THE WIRE IN A TRAPPED STATE COULD HAVE THEN CAUSED THE REPORTED TIP SEPARATION. IN THIS CASE, IT WAS REPORTED THAT RESISTANCE WAS FELT WHEN THE DEVICE WAS MANIPULATED AND SOME FORCE WAS APPLIED AND RESULTED THE GUIDE WIRE SEPARATION. THE INSTRUCTIONS FOR USE (IFU) STATES: DO NOT PUSH, AUGER, WITHDRAW OR TORQUE A GUIDE WIRE THAT MEETS RESISTANCE. TORQUE A GUIDE WIRE IF THE TIP BECOMES ENTRAPPED WITHIN THE VASCULATURE. ALLOW THE GUIDE WIRE TIP TO REMAIN IN A PROLAPSED CONDITION. FAILURE TO DO SO MAY RESULT IN VESSEL TRAUMA, GUIDE WIRE DAMAGE, GUIDE WIRE TIP SEPARATION, OR STENT DAMAGE. IF RESISTANCE IS OBSERVED AT ANY TIME, DETERMINE THE CAUSE UNDER FLUOROSCOPY AND TAKE REMEDIAL ACTION AS NEEDED. REPORTEDLY, AN ATTEMPT WAS MADE TO RETRIEVE THE SEPARATED PORTION OF THE GUIDE WIRE WITH A SNARE DEVICE, HOWEVER, IT WAS NOT SUCCESSFUL AND A PORTION OF THE SEPARATED GUIDE WIRE REMAINS IN THE PATIENT BETWEEN THE STENT AND THE VESSEL WALL AND HOSPITALIZATION WAS REQUIRED. THE REPORTED GUIDE WIRE SEPARATION, INABILITY TO REMOVE, FOREIGN BODY IN PATIENT, REMOVAL OF FOREIGN BODY IN PATIENT, ADDITIONAL THERAPY/NON-SURGICAL TREATMENT AND HOSPITALIZATION APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED THE REPORTED EVENT. TO ENSURE THAT GUIDE WIRE TIP SEPARATION DOES NOT OCCUR AS A RESULT OF A PRODUCT QUALITY DEFICIENCY, MANUFACTURING PERFORMS A NON DESTRUCTIVE TIP PULL TEST ON EACH WIRE, AND PERFORMS 100% VISUAL INSPECTION PRIOR TO PACKAGING. ADDITIONALLY, QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY PRODUCT QUALITY.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL REPORTED INFORMATION INDICATES THAT THE GUIDE WIRE WAS BEING HANDLED THROUGH THE STENT STRUT IN THE LEFT ANTERIOR DESCENDING ARTERY WHILE JAILING THE DIAGONAL ARTERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CORONARY ANGIOPLASTY IN THE FIRST DIAGONAL ARTERY, TWENTY MINUTES AFTER THE START OF THE PROCEDURE, DURING WITHDRAWAL OF THE BALANCE MIDDLEWEIGHT HYDROCOAT GUIDE WIRE, RESISTANCE WAS FELT AND THE DEVICE WAS MANIPULATED WITH SOME FORCE APPLIED. THE GUIDE WIRE SEPARATED WITHIN A NON-ABBOTT STENT. A GOOSE NECK SNARE WAS USED TO RETRIEVE THE PROXIMAL PORTION OF THE GUIDE WIRE. THE DISTAL PORTION OF THE GUIDE WIRE REMAINED COMPRESSED BETWEEN THE STENT AND THE VESSEL. THE PROCEDURE WAS PROLONGED FOR AN ADDITIONAL TWO HOURS AND HOSPITALIZATION WAS PROLONGED AN ADDITIONAL TWO DAYS. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATIN GUIDE WIRE DQX AV-BARCELONETA 0052071

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R CONCOMITANT MEDICAL DEVICES