BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZ SUPER STIFF GUIDEWIRE

    MDR report key: 3122844 · Received May 21, 2013

    Report

    Report Number
    2134265-2013-03433
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (HEREDIA)
    Product Code
    DQX
    PMA / PMN Number
    K843012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED FOR ANALYSIS. BEFORE DECONTAMINATION PROCESS, VISUAL INSPECTION WAS PERFORMED. THE DISTAL END STRETCHED, THE DISTAL END KINKED AND BENT AT 251.2CM FROM THE PROXIMAL END TO DISTAL END; AND JUMPED COILS AT 237.6CM AND AT 238.5CM FROM THE PROXIMAL END. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CORONARY INTERVENTION THE WIRE GOT STUCK AND PEELING WAS NOTED. ACCESS WAS OBTAINED VIA LEFT COMMON FEMORAL ARTERY TRYING TO GO TO THE LEFT COMMON ILLIAC ARTERY. THE AMPLATZ GUIDE WIRE GOT STUCK WHEN THEY PULLED IT BACK TO THE PREVIOUS POSITION. THE DOCTOR PULLED OUT THE ENTIRE SHEATH SYSTEM IN ORDER TO REMOVE THE WIRE WITH NO ISSUE. THE PHYSICIAN LOOKED AT THE GUIDE WIRE AND NOTICED THAT THE WIRE HAD "A LITTLE BUMP AND THE COATING WAS ALMOST PULLED BACK A LITTLE BIT". THE PHYSICIAN INSERTED ANOTHER NEW SHEATH AND USED A NON-BSC GUIDEWIRE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CORONARY INTERVENTION THE WIRE GOT STUCK AND PEELING WAS NOTED. ACCESS WAS OBTAINED VIA LEFT COMMON FEMORAL ARTERY TRYING TO GO TO THE LEFT COMMON ILIAC ARTERY. THE AMPLATZ GUIDE WIRE GOT STUCK WHEN THEY PULLED IT BACK TO THE PREVIOUS POSITION. THE DOCTOR PULLED OUT THE ENTIRE SHEATH SYSTEM IN ORDER TO REMOVE THE WIRE WITH NO ISSUE. THE PHYSICIAN LOOKED AT THE GUIDE WIRE AND NOTICED THAT THE WIRE HAD "A LITTLE BUMP AND THE COATING WAS ALMOST PULLED BACK A LITTLE BIT." THE PHYSICIAN INSERTED ANOTHER NEW SHEATH AND USED A NON-BSC GUIDEWIRE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224355 AMPLATZ SUPER STIFF GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) M001465260 15870860

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR