BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIPWIRE HYDROPHILIC GUIDE WIRE

    MDR report key: 2689311 · Received August 9, 2012

    Report

    Report Number
    2134265-2012-04557
    Event Type
    Injury
    Date Received
    August 9, 2012
    Date of Event
    July 11, 2012
    Report Date
    July 11, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K000011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: EXAMINATION OF THE RETURNED DEVICE REVEALED THE SPECIMEN THE SPECIMEN WAS RECEIVED TRIMMED TO A LENGTH OF 13.95CM WITH APPROXIMATELY 9.30CM OF CORE WIRE EXPOSED DUE TO CUT DAMAGE TO THE POLYMER JACKET MATERIAL AND A CORRESPONDING PORTION OF THE JACKET MATERIAL IS MISSING. THE CUT DAMAGE APPEARS TO ORIGINATE 9.80CM FROM THE EXPOSED DISTAL END OF THE CORE WIRE. THE SPECIMEN PRESENTS A KINK LOCATED 2.85 TO 2.90CM FROM THE EXPOSED DISTAL END OF THE CORE WIRE. THE SPECIMEN ALSO PRESENTS A LARGE RADIUS SPIRAL BEND OVER THE DISTAL 9.5CM OF THE SEGMENT. THE SPECIMEN PRESENTS DRIED BLOOD-LIKE MATERIAL IMBEDDED WITHIN THE COATING, ON THE CUT SURFACE OF THE POLYMER JACKET MATERIAL AND ON THE EXPOSED CORE WIRE SURFACE. THE SPECIMEN COATING APPEARS VISUALLY AND TACTILELY CONSISTENT WHEN EXAMINED UNAIDED, AND WET. AFTER ALLOWING IT TO DRY OUT, WHEN EXAMINED UNAIDED, THE VISUAL AND TACTILE SURFACE APPEARANCE OF THE SPECIMEN IS ACCEPTABLE PER THE INSPECTION CRITERIA. MICROSCOPICALLY THE SPECIMEN COATING APPEARS TO BE SMOOTH AND CONSISTENT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INTRAVENOUS ACCESS DEVICE PLACEMENT PROCEDURE, THE GUIDE WIRE COATING DETACHED. THE INTENDED LOCATION FOR PLACEMENT OF THE INTRAVENOUS ACCESS DEVICE (IVAD) WAS THE SUBCLAVIAN ARTERY. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT SUBCLAVIAN ARTERY (SCA). A 035/150 ZIPWIRE HYDROPHILIC GUIDE WIRE WAS ADVANCED AND PLACED AT THE SCA WITHOUT DIFFICULTY OR RESISTANCE. HOWEVER WHEN THE PHYSICIAN TRIED TO INTRODUCE THE ZIPWIRE FURTHER INTO THE SCA IT BECAME LODGED WITHIN THE SCA. UNDER FLUOROSCOPY, THE DISTAL END OF THE ZIPWIRE APPEARED TO BE KNOTTED AND WHEN RETRACTED THE COATING ON THE TIP OF THE ZIPWIRE CAME OFF. IT WAS CLEARLY IDENTIFIED UNDER FLUOROSCOPY THAT THE COATING FROM THE TIP OF THE ZIPWIRE WAS LODGED IN THE SCA. THE REMAINING PORTION OF THE ZIPWIRE WAS REMOVED. PHYSICIAN CONSULT WAS PERFORMED, AND IT WAS DECIDED TO LEAVE THE DETACHED ZIPWIRE COATING AS IS. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INTRAVENOUS ACCESS DEVICE PLACEMENT PROCEDURE, THE GUIDE WIRE COATING DETACHED. THE INTENDED LOCATION FOR PLACEMENT OF THE INTRAVENOUS ACCESS DEVICE (IVAD) WAS THE SUBCLAVIAN ARTERY. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT SUBCLAVIAN ARTERY (SCA). A 035/150 ZIPWIRE HYDROPHILIC GUIDE WIRE WAS ADVANCED AND PLACED AT THE SCA WITHOUT DIFFICULTY OR RESISTANCE. HOWEVER, WHEN THE PHYSICIAN TRIED TO INTRODUCE THE ZIPWIRE FURTHER INTO THE SCA IT BECAME LODGED WITHIN THE SCA. UNDER FLUOROSCOPY, THE DISTAL END OF THE ZIPWIRE APPEARED TO BE KNOTTED AND WHEN RETRACTED THE COATING ON THE TIP OF THE ZIPWIRE CAME OFF. IT WAS CLEARLY IDENTIFIED UNDER FLUOROSCOPY THAT THE COATING FROM THE TIP OF THE ZIPWIRE WAS LODGED IN THE SCA. THE REMAINING PORTION OF THE ZIPWIRE WAS REMOVED. PHYSICIAN CONSULT WAS PERFORMED, AND IT WAS DECIDED TO LEAVE THE DETACHED ZIPWIRE COATING AS IS. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIPWIRE HYDROPHILIC GUIDE WIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE M00146318B0

    Patients

    Seq Age Sex Outcome Treatment
    1 Other