BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIPWIRE HYDROPHILIC GUIDE WIRE

    MDR report key: 2021540 · Received March 17, 2011

    Report

    Report Number
    2134265-2011-00628
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 17, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K000011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS PARTIALLY RELOADED INTO THE PARTIAL DISPENSER ASSEMBLY (LESS THE J-STRAIGHTENER/INTRODUCER). NO OTHER DEVICES INVOLVED IN THE REPORTED EVENT WERE RETURNED. AS RECEIVED, THE SPECIMEN PRESENTS AN OVERALL LENGTH OF 150.65CM AND A FINISHED DIAMETER WITHIN SPECIFICATION. A GAGE BUSHING CERTIFIED TO BE .0350¿ PASSED OVER THE LENGTH OF THE SPECIMEN WITH NO MORE EFFORT THAN THE MASS OF THE BUSHING SLIDING DOWN THE WIRE SHAFT UNAIDED. THE SPECIMEN PRESENTS A CUT OR SKIVE DAMAGE LOCATED 14.40 TO 16.10CM FROM THE DISTAL TIP WITH A PROXIMAL TO DISTAL ORIENTATION. THERE ALSO APPEARS TO BE A SECOND AREA OF SKIVE AND PROLAPSE DAMAGE TO THE POLYMER JACKET MATERIAL LOCATED 19.75 TO 21.9010CM FROM THE DISTAL TIP WITH A PROXIMAL TO DISTAL ORIENTATION. THE SPECIMEN COATING APPEARS VISUALLY AND TACTILELY CONSISTENT WHEN EXAMINED UNAIDED, WET. AFTER ALLOWING IT TO DRY OUT, THE VISUAL AND TACTILE SURFACE APPEARANCE OF THE SPECIMEN IS ACCEPTABLE. MICROSCOPICALLY THE SPECIMEN COATING APPEARS TO BE SMOOTH AND CONSISTENT OVER THE LENGTH OF THE SPECIMEN WITH WEAR AND ABRASION CONSISTENT WITH CLINICAL USE SCATTERED OVER THE LENGTH OF THE SPECIMEN. 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 A BRAIN ANGIOGRAPHY AND EMBOLIZATION TREATMENT PROCEDURE, GUIDE WIRE ENTRAPMENT AND GUIDE WIRE COATING DAMAGE OCCURRED. THE PROCEDURE WAS TO TREAT A BRAIN ANEURYSM. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL. A PUNCTURE NEEDLE WAS INSERTED AND THIS 035/150 ZIPWIRE WAS ADVANCED INSIDE THE PATIENT AGAINST RESISTANCE. THE PUNCTURE NEEDLE WAS THEN REMOVED. ANOTHER MANUFACTURERS' INTRODUCER SHEATH WAS SELECTED; HOWEVER, THE "SHIRT" AND DILATOR WOULD NOT ADVANCE OVER THE ZIPWIRE. THE DILATOR BECAME STUCK ON THE ZIPWIRE, THE "SHIRT" DID NOT. THE DILATOR AND ZIPWIRE WERE REMOVED FROM THE PATIENT TOGETHER, AT WHICH POINT IT WAS NOTED THAT THE HYDOPHILIC COATING WAS "BROKEN". THE COATING DAMAGE OCCURRED ON A SECTION OF THE WIRE LOCATED OUTSIDE THE PATIENT. THE ZIPWIRE DID NOT FRACTURE/DETACH AND NOTHING WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ZIPWIRE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BRAIN ANGIOGRAPHY AND EMBOLIZATION TREATMENT PROCEDURE, GUIDE WIRE ENTRAPMENT AND GUIDE WIRE COATING DAMAGE OCCURRED. THE PROCEDURE WAS TO TREAT A BRAIN ANEURYSM. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL. A PUNCTURE NEEDLE WAS INSERTED AND THIS 035/150 ZIPWIRE WAS ADVANCED INSIDE THE PATIENT AGAINST RESISTANCE. THE PUNCTURE NEEDLE WAS THEN REMOVED. ANOTHER MANUFACTURERS' INTRODUCER SHEATH WAS SELECTED; HOWEVER, THE "SHIRT" AND DILATOR WOULD NOT ADVANCE OVER THE ZIPWIRE. THE DILATOR BECAME STUCK ON THE ZIPWIRE, THE "SHIRT" DID NOT. THE DILATOR AND ZIPWIRE WERE REMOVED FROM THE PATIENT TOGETHER, AT WHICH POINT IT WAS NOTED THAT THE HYDOPHILIC COATING WAS "BROKEN". THE COATING DAMAGE OCCURRED ON A SECTION OF THE WIRE LOCATED OUTSIDE THE PATIENT. THE ZIPWIRE DID NOT FRACTURE/DETACH AND NOTHING WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ZIPWIRE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIPWIRE HYDROPHILIC GUIDE WIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE M00146151B0 0001424143

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR CORDIS INTRODUCER SHEATH WITH DILATOR