BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 3930241 · Received July 11, 2014

    Report

    Report Number
    2024168-2014-04466
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 16, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND THE REPORTED DETACHMENT OF THE DEVICE WAS CONFIRMED ALTHOUGH THE PHYSICAL RESISTANCE AND DIFFICULT TO REMOVE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON THE VISUAL AND DIMENSIONAL, ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY/REVIEW OF THE COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. IT SHOULD BE NOTED THE HI TORQUE GUIDE WIRES INSTRUCTIONS FOR USE (IFU) STATES: DO NOT PUSH, AUGER, WITHDRAW OR TORQUE A GUIDE WIRE THAT MEETS RESISTANCE, OR TORQUE A GUIDE WIRE IF THE TIP BECOMES ENTRAPPED WITHIN THE VASCULATURE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). EXCESSIVE FORCE. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE FOR ACUTE CORONARY SYNDROME (ACS) ST WITH TROPO+ THERE WAS ONE TIGHT LESION OF THE DISTAL CIRCUMFLEX (CX) AND ONE TIGHT LESION OF THE LEFT MARGINAL 1. DIFFICULTY WAS NOTED WHILE ATTEMPTING TO CROSS THE LESION WITH THE BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE. THE GUIDE WIRE WAS PUSHED DISTALLY IN THE CIRCUMFLEX, DISTALLY TO THE LEFT MARGINAL LEVEL. A KISSING TECHNIQUE USING A SECOND BMW WAS POSITIONED IN THE LEFT MARGINAL 1. A BALLOON DILATATION WAS PERFORMED AND A LONG NON-ABBOTT DRUG-ELUTING STENT (DES) WAS PLACED AT THE CX1 AND CX2. A DISSECTION CONSECUTIVE TO THE DES DEPLOYMENT WAS NOTED. A SHORT NON-ABBOTT BARE METAL STENT (BMS) WAS IMPLANTED DISTALLY TO THE DES WITHOUT DIFFICULTY OVER THE BMW GUIDE WIRE. THE BMW GUIDE WIRE IN THE LEFT MARGINAL 1 WAS REMOVED WITHOUT ISSUE. THE BMW GUIDE WIRE IN THE DISTAL CIRCUMFLEX MET RESISTANCE DURING REMOVAL AND FORCE WAS USED TO SUCCESSFULLY REMOVE THE DEVICE FROM THE ANATOMY. OUTSIDE THE ANATOMY THE LENGTH WAS NOTED TO BE 189.7 CM INSTEAD OF 190 CM. IT WAS OBSERVED THAT 3 MM OF THE FLOPPY TIP HAD DETACHED AND REMAINED IN A VERY SMALL BRANCH AT THE DISTAL CIRCUMFLEX ARTERY. NO ATTEMPT TO REMOVE THE GUIDE WIRE FRAGMENT WAS MADE. AND THERE WAS NO SPECIFIC TREATMENT PERFORMED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406531 ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING GUIDE WIRE DQX AV-TEMECULA-CT 4042371

    Patients

    Seq Age Sex Outcome Treatment
    1 Other