BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE

    MDR report key: 772751 · Received August 17, 2006

    Report

    Report Number
    2024168-2006-00509
    Event Type
    Malfunction
    Date Received
    August 17, 2006
    Date of Event
    July 14, 2006
    Report Date
    July 18, 2006
    Manufacturer
    GUIDANT VASCULAR INTERVENTION
    Product Code
    DQX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO COMPLETE THEIR ANALYSIS AT TIME OF THIS REPORT. RESULTS AND CONCLUSION WILL BE FORWARDED UPON COMPLETION. THE OTHER BMW UNIVERSAL GUIDE WIRES MENTIONED IN THE EVENT DESCRIPTION (B5) AND D11 ARE BEING FILED UNDER THE SAME MFR NUMBER. QUALITY ASSURANCE ANALYSIS REVEALED THAT THE FIRST GUIDE WIRE, LOT NUMBER 6041754, WAS RETURNED WITHOUT ANY BLOOD VISIBLE. THERE WAS CONTRAST VISIBLE ON THE COILS AND ON THE CORE. THE TIP WAS IN A HOOK SHAPE. THE CORE WAS SEPARATED AT THE PROXIMAL END OF THE HYPOTUBE. THE FRACTURE FACES WERE UNEVEN AND SLIGHTLY BENT. THERE WAS A SMALL PIECE OF THE CORE PROTRUDING FROM THE PROXIMAL END OF THE HYPOTUBE WHERE THE SEPARATION OCCURRED. THERE WAS NO OTHER DAMAGE TO THE GUIDE WIRE NOTED. THE SECOND GUIDE WIRE, LOT NUMBER 6041754, WAS RETURNED WITHOUT ANY BLOOD VISIBLE. THERE WAS CONTRAST VISIBLE ON THE COILS AND ON THE CORE. THE SHAPING RIBBON WAS SLIGHTLY BENT. THE CORE WAS SEPARATED AT THE PROXIMAL END OF THE HYPOTUBE. THE FRACTURE FACES WERE UNEVEN AND BENT. THERE WAS A SMALL PIECE OF THE CORE PROTRUDING FROM THE PROXIMAL END OF THE HYPOTUBE WHERE THE SEPARATION OCCURRED. THERE WERE KINKS IN THE CORE 1.2 CM AND 3.7 CM PROXIMAL TO THE CORE SEPARATION. THERE WAS A BEND IN THE CORE 15 CM DISTAL TO THE COINED END. THERE WAS NO OTHER DAMAGE TO THE GUIDE WIRE NOTED. THE THIRD WIRE, LOT NUMBER 6051853, WAS RETURNED WITHOUT ANY BLOOD OR CONTRAST VISIBLE. THE CORE WAS SEPARATED AT THE PROXIMAL AND DISTAL ENDS OF THE HYPOTUBE, LEAVING THE HYPOTUBE COMPLETELY SEPARATED FROM THE GUIDE WIRE. THE FRACTURE FACES WERE UNEVEN AND SLIGHTLY BENT. THERE WAS A SMALL PIECE OF THE CORE PROTRUDING FROM BOTH THE PROXIMAL AND DISTAL ENDS OF THE HYPOTUBE WHERE THE SEPARATIONS OCCURRED.THERE WAS NO OTHER DAMAGE TO THE GUIDE WIRE NOTED. THE FOURTH GUIDE WIRE, LOT NUMBER 6053151, WAS RETURNED WITHOUT ANY BLOOD OR CONTRAST VISIBLE. THE CORE WAS SEPARATED AT THE PROXIMAL END OF THE HYPOTUBE. THE FRACTURE FACES WERE UNEVEN AND BENT. THERE WAS A SMALL PIECE OF THE CORE PROTRUDING FROM THE PROXIMAL END OF THE HYPOTUBE WHERE THE SEPARATION OCCURRED.THERE WAS A KINK IN THE CORE 2.8 CM PROXIMAL TO THE SEPARATION. THERE WAS NO OTHER DAMAGE TO THE GUIDE WIRE NOTED. THE TIPS OF ALL FOUR GUIDE WIRES WERE TUGGED ON CONFIRM THE CORE AND SHAPING RIBBONS WERE INTACT. ALL FOUR OF THE GUIDE WIRES WERE SENT TO SCANNING ELECTRON MICROSCOPY (SEM) FOR FURTHER ANALYSIS. PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO COMPLETE THEIR ANALYSIS AT TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION.

    Description of Event or Problem · 1

    REPORTS STATUS: MALFUNCTION. REPORT RATIONALE: GUIDE WIRE SEPARATION HAS CAUSED OR CONTRIBUTED TO PATIENT INJURY PREVIOUSLY. DEVICE ISSUE: GUIDE WIRE SEPARATION. IT WAS REPORTED THAT AN ATTEMPT WAS MADE ADVANCE THE BMW UNIVERSAL GUIDE WIRE (LOT 6041754) TO THE LESION, BUT IT WOULD NOT CROSS. THEN THE GUIDE WIRE WAS REMOVED OUT OF THE PATIENT'S BODY AND STORED ON THE TRAY. A INTERMEDIATE GUIDE WIRE AND A CATHETER CROSSED THE LESION. THEN THE INTERMEDIATE WAS CHANGED TO THE BMW UNIVERSAL THAT WAS USED PREVIOUSLY. WHEN THE BMW UNIVERSAL WAS REMOVED FROM THE TRAY, THE GUIDE WIRE WAS FOUND TO BE SEPARATED AT THE HYPOTUBE. THUS, A NEW BMW UNIVERSAL OF THE SAME LOT WAS SELECTED AND THE PROCEDURE WAS CONTINUED. AFTER THE PROCEDURE, THE PHYSICIAN TESTED THE DEVICE STRENGTH OF THE SECOND GUIDE WIRE THAT WAS USED FOR THE PROCEDURE BY BENDING THE GUIDE WIRE. THE GUIDE WIRE SEPARATED EASILY AT THE HYPOTUBE. HE TESTED TWO OTHER NEW BMW UNIVERSAL GUIDE WIRES AND BOTH OF THEM SEPARATED EASILY AS WELL. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE GUIDE WIRE DQX GUIDANT VASCULAR INTERVENTION NA 6041754

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN GW: (3) BMW UNIVERSAL (LOT# 6041754, 6051853,| OTHER: NAVICATH| PILOT 50| STENT: PIXEL 2.5X23| INTERMEDIATE GC: HEARTRAIL 6F BL 3.5| 6053151),| DC: RYUJIN PLUS 1.25X15| MAVERICK 2 2.0X15