BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE WHISPER GUIDE WIRE

    MDR report key: 1902319 · Received November 11, 2010

    Report

    Report Number
    2024168-2010-02412
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    August 30, 2010
    Report Date
    October 22, 2010
    Manufacturer
    ABBOTT VASCULAR-MURRIETA
    Product Code
    DQX
    PMA / PMN Number
    K013092
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INABILITY TO CROSS THE LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRODUCT PLACEMENT TECHNIQUE, PRODUCT SIZE SELECTION AND ACCESSORY DEVICE SUPPORT; AND IS TYPICALLY NOT ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY. HAVING THE APPROPRIATE EQUIPMENT SELECTED FOR USE, RELATED TO THE CASE CONDITIONS, CAN ALSO SIGNIFICANTLY AFFECT CROSSING AND IT IS EXPECTED THAT WIRES WITH DIFFERENT PERFORMANCE PROPERTIES WOULD PERFORM DIFFERENTLY IN CROSSING ATTEMPTS. IT WAS REPORTED THAT THE VESSEL WAS HEAVILY TORTUOUS AND THE LESION WAS HEAVILY CALCIFIED WHICH LIKELY CONTRIBUTED TO THE REPORTED INABILITY CROSSING THE LESION AND LIKELY THE RESULT OF THE GUIDE WIRE TIP SEPARATION. GUIDE WIRE TIP SEPARATION OF THIS NATURE MAY HAPPEN WHEN THE CORE IS SUBJECTED TO TENSILE OR TORSIONAL LOADS BEYOND ITS DESIGN LIMITS CAUSING THE DISTAL 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 GUIDE WIRE BEING OVER PULLED OR OVER TORQUED WOULD REQUIRE THE TIP TO BE TRAPPED, IN THIS CASE, WITHIN THE ANATOMY OR ANOTHER DEVICE IN ORDER TO CREATE THE REQUIRED FORCES TO DAMAGE THE WIRE AS DESCRIBED. THERE WAS NO DEFINITE INDICATION IN THE CASE DESCRIPTION AS TO WHAT MAY HAVE CAUSED THE WIRE TO BECOME TRAPPED; HOWEVER, PATIENT ANATOMY, LESION MORPHOLOGY, AND/OR RESISTANCE BETWEEN THE PRODUCTS CAN ALL BE FACTORS. IN THIS CASE, THE VESSEL WAS DESCRIBED AS HEAVILY TORTUOUS AND THE LESION WAS HEAVILY CALCIFIED, WHICH MAY HAVE CONTRIBUTED TO THE GUIDE WIRE BECOMING TRAPPED. IT WAS REPORTED THAT THE PHYSICIAN USED VERY AGGRESSIVE GUIDE CATHETER WORK (DEEP SEATING THE GUIDE CATHETER) AND MULTIPLE EXCHANGES AND PER THE PHYSICIAN PROBABLY STRESSED THE GUIDE WIRE WHICH LIKELY CONTRIBUTED TO THE REPORTED GUIDE WIRE TIP SEPARATION. AN ADDITIONAL THERAPY/NON-SURGICAL TREATMENT WAS USED TO RETRIEVE THE SEPARATED PORTION WITH A SNARE DEVICE. ANY ATTEMPTS TO MOVE THE GUIDE WIRE IN A TRAPPED STATE WOULD HAVE THEN CAUSED THE REPORTED TIP SEPARATION. PER INSTRUCTIONS FOR USE (IFU): 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. NO DAMAGE TO THE GUIDE WIRE TIP WAS REPORTED PRIOR TO USE, WHICH COULD INDICATE THAT THE DAMAGE WAS LIKELY NOT PRE-EXISTING. THE GUIDE WIRE WAS NOT RETURNED WHICH MAY HAVE AIDED IN THE EVALUATION. THE REPORTED INABILITY TO CROSS THE LESION, GUIDE WIRE TIP SEPARATION, ADDITIONAL THERAPY/NON-SURGICAL TREATMENT, REMOVAL OF FOREIGN BODY USING A SNARE DEVICE APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. MANUFACTURING PERFORMS A NON DESTRUCTIVE TIP PULL TEST ON EACH WIRE, AND PERFORMS 100% OUTER DIAMETER INSPECTION PRIOR TO PACKAGING. ADDITIONALLY, QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY PRODUCT QUALITY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE GUIDE WIRE WAS DISCARDED. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD WILL NOT BE PERFORMED. A F/U WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    REPORTEDLY, THE GUIDE WIRE BROKE 3 CM FROM THE TIP AFTER SEVERAL FAILED ATTEMPTS TO CROSS THROUGH A GRAFT IN THE POSTERIOR DESCENDING ARTERY (PDA) TO TREAT A LESION MORE DISTAL. THE PHYSICIAN USED VERY AGGRESSIVE GUIDE CATHETER WORK AND MULTIPLE EXCHANGES WHICH PER THE PHYSICIAN PROBABLY STRESSED THE GUIDE WIRE. THE SEPARATED TIP WAS SUCCESSFULLY SNARED OUTSIDE OF THE PT ANATOMY WITHOUT FURTHER INCIDENT. THE PROCEDURE WAS COMPLETED USING ANOTHER WHISPER GUIDE WIRE. THERE WERE NO PT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION WAS RECEIVED STATING: THE PHYSICIAN USED VERY AGGRESSIVE GUIDE CATHETER WORK WHICH INVOLVED DEEP SEATING THE GUIDE CATHETER AND MULTIPLE EXCHANGES WHICH INVOLVED ADVANCING BALLOONS ACROSS THE GUIDE WIRE TO DILATE THE DISTAL SEGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE WHISPER GUIDE WIRE GUIDE WIRES DQX ABBOTT VASCULAR-MURRIETA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention