BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLADIATOR¿

    MDR report key: 2963775 · Received February 15, 2013

    Report

    Report Number
    2134265-2013-00793
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K113681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: INITIAL EXAMINATION OF THE RETURNED DEVICE NOTED THAT THE BALLOON MATERIAL WAS TORN BOTH PARTIALLY CIRCUMFERENTIAL AND LONGITUDINALLY. THE PARTIAL CIRCUMFERENTIAL TEAR WAS LOCATED AT APPROXIMATELY 2MM DISTAL TO THE PROXIMAL TRANSITION ZONE. IT WAS TORN LONGITUDINALLY FOR A DISTANCE OF 14MM APPROXIMATELY 2MM DISTAL TO THE PROXIMAL TRANSITION ZONE. A VISUAL AND TACTILE EXAMINATION OF THE SHAFT OF THE DEVICE WAS KINKED AT 240MM AND 270MM DISTAL TO THE STRAIN RELIEF. 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 A CEPHALIC ARCH STENOSIS ANGIOPLASTY PROCEDURE A BALLOON RUPTURE AND TEAR OCCURRED. THE TARGET LESION WAS AN INSTENT RESTENOSIS OF AN UNSPECIFIED STENT, LOCATED IN A NOT HIGHLY CALCIFIED AND NOT VERY TORTUOUS CEPHALIC ARCH. THE 9.0 X 40MM, 75CM GLADIATOR BALLOON CATHETER WAS SELECTED FOR TREATMENT. THE BALLOON WAS INFLATED AND RUPTURE AT 14ATM. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT. THE PHYSICIAN NOTED TEARING AROUND THE BALLOON UPON INSPECTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER WITH SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS' STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CEPHALIC ARCH STENOSIS ANGIOPLASTY PROCEDURE, A BALLOON RUPTURE AND TEAR OCCURRED. THE TARGET LESION WAS AN INSTENT RESTENOSIS OF AN UNSPECIFIED STENT, LOCATED IN A NOT HIGHLY CALCIFIED AND NOT VERY TORTUOUS CEPHALIC ARCH. THE 9.0 X 40 MM, 75 CM GLADIATOR BALLOON CATHETER WAS SELECTED FOR TREATMENT. THE BALLOON WAS INFLATED AND RUPTURE AT 14 ATM. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT. THE PHYSICIAN NOTED TEARING AROUND THE BALLOON UPON INSPECTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER WITH SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT' STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66794 GLADIATOR¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939207090470 15695274

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR