BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIPWIRE HYDROPHILIC GUIDE WIRE

    MDR report key: 1859744 · Received October 7, 2010

    Report

    Report Number
    2134265-2010-04442
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    July 30, 2010
    Report Date
    September 13, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K000011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: ANALYSIS OF THE RETURNED DEVICE REVEALED THE DEVICE PRESENTED AN OVERALL LENGTH OF 261CM AND A FINISHED DIAMETER OF .030315" TO .033240". A 17.3CM SEGMENT OF POLYMER JACKET MATERIAL HAS BEEN SKIVED FROM THE DEVICE, EXPOSING 17.2CM OF CORE WIRE IN A PROXIMAL TO DISTAL ORIENTATION, TERMINATING 8CM FROM THE DISTAL TIP. THE EDGES OF THE SKIVED POLYMER JACKET MATERIAL PRESENT IMBEDDED BLOOD-LIKE MATERIAL. MICROSCOPIC INSPECTION OF THE DEVICE OBSERVED THAT THE COATING APPEARS TO BE SMOOTH AND CONSISTENT OVER THE LENGTH OF THE DEVICE WITH SCATTERED MINOR WEAR AND ABRASION. THE DEVICE PRESENTS NO OTHER DAMAGE OR INCONSISTENCIES. THE MANUFACTURING BATCH RECORD REVIEW COULD NOT BE COMPLETED AS THE BATCH NUMBER WAS UNKNOWN. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED USER RELATED AS THE DFU INDICATES A PLASTIC ENTRY NEEDLE IS RECOMMENDED WHEN USING THIS WIRE FOR INITIAL PLACEMENT AND DEVICE ANALYSIS REVEALED INDICATIONS OF AXIAL SHEAR/SKIVE DAMAGE CONSISTENT WITH WITHDRAWING THE DEVICE THROUGH A METAL NEEDLE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION TREATMENT PROCEDURE, A PORTION OF THE GUIDE WIRE DETACHED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL. THE 035/180 ZIPWIRE HYDROPHILIC GUIDE WIRE WAS INSERTED INTO A NON BSC 18 GAUGE PERCUTANEOUS NEEDLE. AFTER PLACEMENT OF AN UNSPECIFIED INTRODUCER SHEATH, IT WAS NOTED THAT A PORTION OF THE GUIDE WIRE HAD DETACHED IN THE RIGHT FEMORAL VEIN. UTILIZING A NON BSC SNARING DEVICE, THE WIRE FRAGMENT WAS REMOVED THROUGH THE SHEATH. A FULL CINE WAS THEN PERFORMED ENSURING NO FRAGMENTS REMAINED IN THE PATIENT AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION TREATMENT PROCEDURE, A PORTION OF THE GUIDE WIRE DETACHED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL. THE 035/180 ZIPWIRE HYDROPHILIC GUIDE WIRE WAS INSERTED INTO A NON BSC 18 GAUGE PERCUTANEOUS NEEDLE. AFTER PLACEMENT OF AN UNSPECIFIED INTRODUCER SHEATH, IT WAS NOTED THAT A PORTION OF THE GUIDE WIRE HAD DETACHED IN THE RIGHT FEMORAL VEIN. UTILIZING A NON BSC SNARING DEVICE, THE WIRE FRAGMENT WAS REMOVED THROUGH THE SHEATH. A FULL CINE WAS THEN PERFORMED ENSURING NO FRAGMENTS REMAINED IN THE PATIENT AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIPWIRE HYDROPHILIC GUIDE WIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE M00146154B0

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention COOK MEDICAL 18 GAUGE PERCUTANEOUS NEEDLE