BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT WHISPER GUIDE WIRES WITH HYDROPHILIC COATING

    MDR report key: 8865928 · Received August 6, 2019

    Report

    Report Number
    2024168-2019-10601
    Event Type
    Injury
    Date Received
    August 6, 2019
    Date of Event
    July 17, 2019
    Report Date
    October 24, 2019
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQX
    UDI-DI
    08717648037801
    PMA / PMN Number
    K101116
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE CODE 2017 - EXCESSIVE FORCE/INCORRECT REMOVAL DEVICE CODE 1494 - INDICATION FOR USE THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. G9: EXEMPTION NUMBER E2019001-PERMITS NUMBERING SEQUENCE TO BEGIN WITH 10000, TO AVOID DUPLICATION OF REPORT NUMBERS DUE TO PROCESS TRANSITION. THERE MAY BE GAPS IN NUMBERING FOR REPORTS SUBMITTED DURING THE TRANSITION PERIOD.NA

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2019001-PERMITS NUMBERING SEQUENCE TO BEGIN WITH 10000, TO AVOID DUPLICATION OF REPORT NUMBERS DUE TO PROCESS TRANSITION. THERE MAY BE GAPS IN NUMBERING FOR REPORTS SUBMITTED DURING THE TRANSITION PERIOD. VISUAL AND DIMENSIONAL INSPECTIONS WERE PERFORMED. THE REPORTED GUIDE WIRE SEPARATION WAS CONFIRMED. THE REPORTED ENTRAPMENT OF THE DEVICE, DIFFICULTY TO ADVANCE/POSITION AND DIFFICULT TO REMOVE WAS UNABLE TO BE CONFIRMED OR REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. BASED ON THE REPORTED INFORMATION AND SIMILAR INCIDENT QUERY THERE IS NO INDICATION OF A LOT SPECIFIC QUALITY ISSUE. IT SHOULD BE NOTED THAT INSTRUCTIONS FOR USE (IFU) GUIDE WIRE HI-TORQUE GUIDE WIRES CE FDA STATES: ALL HI-TORQUE GUIDE WIRES ARE INTENDED TO FACILITATE THE PLACEMENT OF BALLOON DILATATION CATHETERS DURING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). IFU ALSO STATES: IF RESISTANCE IS OBSERVED AT ANY TIME, DETERMINE THE CAUSE UNDER FLUOROSCOPY AND TAKE REMEDIAL ACTION AS NEEDED. DO NOT PUSH, AUGER, WITHDRAW OR TORQUE A GUIDE WIRE THAT MEETS RESISTANCE. IN THIS CASE, THE REPORTED IFU VIOLATION DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED COMPLAINT AS FORCE WAS REQUIRED TO ATTEMPT TO REMOVE THE DEVICE GIVEN THE CLINICAL SITUATION. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LATERAL VEIN FOR A BIVENTRICULAR PACEMAKER PLACEMENT. THE 014 WHISPER WIRE WAS ADVANCED WITHOUT ISSUE TO THE LESION. DURING ATTEMPTED LEAD ADVANCEMENT, THERE WAS RESISTANCE MET WITH THE GW. THEN THE GW MOVED AND BECAME ENTRAPPED IN THE WALL OF THE VEIN. WHEN PULLED WITH MUCH FORCE FOR REMOVAL, RESISTANCE WAS MET WITH THE ANATOMY AND THE 3CM GW TIP DETACHED AND REMAINED EMBEDDED IN THE VEIN WALL. THE REST OF THE GW WAS SIMPLY REMOVED. ANOTHER WHISPER WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661222 HT WHISPER GUIDE WIRES WITH HYDROPHILIC COATING GUIDE WIRE DQX ABBOTT VASCULAR 9050671 08717648037801

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other