BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE

    MDR report key: 1887704 · Received October 26, 2010

    Report

    Report Number
    2024168-2010-02257
    Event Type
    Injury
    Date Received
    October 26, 2010
    Date of Event
    September 23, 2010
    Report Date
    October 5, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). GUIDE WIRE CORE SEPARATION OF THIS NATURE CAN OCCUR BUT IS NOT LIMITED TO WHEN THE CORE IS SUBJECTED TO TENSILE OR TORSIONAL LOADS BEYOND ITS DESIGN LIMITS CAUSING THE CORE TO DETACH. TYPICALLY, THE FRACTURE SITE MORPHOLOGY SHOWS THE CORE TO BE 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. IN THIS CASE, IT WAS REPORTED THE LESION WAS HEAVILY CALCIFIED, WHICH COULD HAVE CONTRIBUTED TO THE REPORTED INABILITY TO REMOVE AND RESULTED IN THE REPORTED GUIDE WIRE SEPARATION. IT WAS REPORTED THAT 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 AND MEDICATIONS WERE REQUIRED. IN ORDER TO ENSURE THAT GUIDE WIRE CORE SEPARATION DOES NOT OCCUR AS A RESULT OF A PRODUCT QUALITY DEFICIENCY, MANUFACTURING PERFORMS A NON DESTRUCTIVE 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. OVERALL, THE REPORTED GUIDE WIRE SEPARATION, INABILITY TO REMOVE, FOREIGN BODY IN PATIENT, ADDITIONAL THERAPY/NON-SURGICAL TREATMENT AND MEDICATIONS APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. A F/U REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED. THIS WAS THE SECOND ATTEMPT TO OPEN A CHRONIC OCCLUDED RIGHT CORONARY ARTERY (RCA), A BMW UNIVERSAL (PLUS 3 ADDITIONAL GUIDE WIRES) AND A TREK BALLOON CATHETER WERE USED TO PASS THE OCCLUSION. TWO 3.0 X 38MM STENTS WERE DEPLOYED AND WERE POST DILATED WITH A VOYAGER NC BALLOON CATHETER. AFTER PULLING BACK THE BMW UNIVERSAL GUIDE WIRE, THE COIL UNTANGLED [SEPARATED] AND A SNARE ATTEMPT WAS MADE, BUT IT WAS UNSUCCESSFUL. THE GUIDE WIRE STAYED IN THE RCA PROBABLY STUCK BECAUSE OF THE HEAVY CALCIFICATION AND THEN IT SEPARATED. ANOTHER ATTEMPT WAS MADE TO SNARE THE GUIDE WIRE, BUT IT REMAINS IN THE RCA WITH 10 CENTIMETERS IN THE AORTA. THE PT DID NOT HAVE ANY COMPLAINTS AND THE RCA IS OPEN. HEPARIN WAS ADMINISTERED AFTER THE PROCEDURE AND ASCAL 1 DD 100 MG AND PLAVIX 1DD 75MG WILL BE CONTINUED FOR ONE (1) YEAR. THE PT WAS DISCHARGED THE NEXT DAY. TWO WEEKS LATER THE CASE WAS DISCUSSED IN THE HEART TEAM WHERE THEY DECIDED THAT BECAUSE IT WAS A SINGLE VESSEL DISEASE AND THE PT HAD NO COMPLAINTS THEY ARE NOT GOING TO DO SURGERY AND THE PT NEEDS TO COME BACK IN ONE YEAR TO SEE IF THEY WILL DO SURGERY THEN. THE PT WILL STAY ON PLAVIX AND ASCAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE GUIDE WIRE DQX ABBOTT VASCULAR-CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other| R VOYAGER NC| GUIDING CATHETER: JR4STENTS: ABBOTT (X2)| PILOT 50 INFLATION: ABBOTT| GUIDE WIRE: FINECROSS| WHISPER