BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLADIATOR?

    MDR report key: 3063389 · Received April 17, 2013

    Report

    Report Number
    2134265-2013-02685
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K113681
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: AN EXAMINATION OF THE DEVICE FOUND THAT A COMPLETE BALLOON CIRCUMFERENTIAL TEAR HAD OCCURRED AT 1CM DISTAL TO THE DISTAL EDGE OF THE PROXIMAL MARKERBAND. A BREAK WAS ALSO PRESENT IN THE SHAFT. THE BREAK WAS LOCATED AT 72.6 CM DISTAL TO THE STRAIN RELIEF. THE DISTAL SECTION OF THE BALLOON MATERIAL WAS NOT RETURNED FOR ANALYSIS. A STRETCHED SECTION OF THE DISTAL SHAFT BREAK, MEASURING 10 CM WAS RETURNED IN A PLASTIC CONTAINER. IT IS NOTED THAT THE BREAK AND STRETCHING THAT WAS EVIDENT ALONG THE SHAFT IS CONSISTENT WITH EXCESSIVE TENSILE FORCE HAVING BEEN APPLIED TO THE SHAFT. A MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL AND PROXIMAL MARKERBAND COULD NOT IDENTIFY ANY ISSUES WHICH COULD POTENTIALLY HAVE CONTRIBUTED TO THE BALLOON TEAR. 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 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, A BALLOON RUPTURE AND DETACHMENT OCCURRED. TREATMENT WAS A DIALYSIS FISTULA OF THE ARM. A 8.0 X 40, 75CM GLADIATOR BALLOON WAS INFLATED ONCE AND RUPTURED AT 20 ATMS. NEGATIVE PRESSURE WAS APPLIED WITH THE INFLATION DEVICE "TO DROP BALLOON" AND THE DEVICE WAS REMOVED. FOLLOWING REMOVAL IT WAS NOTED THAT HALF OF THE BALLOON MATERIAL WAS MISSING AS WELL AS THE VERY DISTAL PART OF THE SHAFT. AN ATTEMPT AT RETRIEVAL WITH A SNARE WAS UNSUCCESSFUL. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AD THE PATIENT'S CONDITION WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, A BALLOON RUPTURE AND DETACHMENT OCCURRED. TREATMENT WAS A DIALYSIS FISTULA OF THE ARM. A 8.0 X 40, 75CM GLADIATOR BALLOON WAS INFLATED ONCE AND RUPTURED AT 20 ATMS. NEGATIVE PRESSURE WAS APPLIED WITH THE INFLATION DEVICE "TO DROP BALLOON" AND THE DEVICE WAS REMOVED. FOLLOWING REMOVAL IT WAS NOTED THAT HALF OF THE BALLOON MATERIAL WAS MISSING AS WELL AS THE VERY DISTAL PART OF THE SHAFT. AN ATTEMPT AT RETRIEVAL WITH A SNARE WAS UNSUCCESSFUL. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AD THE PATIENT'S CONDITION WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165756 GLADIATOR? CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939207080470 0015690991

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention