BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 1822261 · Received September 1, 2010

    Report

    Report Number
    2134265-2010-03990
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 3, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: RETURNED PRODUCT CONSISTED OF A STERLING OVER THE WIRE BALLOON CATHETER WITH NO OTHER DEVICES AND NO ORIGINAL PACKAGING. IT WAS NOTED DURING UNPACKAGING THAT DRIED BLOOD AND CONTRAST WERE PRESENT ON THE OUTER SURFACES OF THE DEVICE. VISUAL AND TACTILE EXAMINATION OF THE PROXIMAL HUB AND SHAFT PRESENTED NO DAMAGE OR IRREGULARITIES. MICROSCOPIC EXAMINATION OF THE DISTAL END OF THE CATHETER REVEALED A LONGITUDINAL TEAR IN THE BALLOON WALL. THE TEAR WAS APPROXIMATELY 15 MM LONG. MAGNIFIED INSPECTION OF THE BALLOON MATERIAL AT THE EDGES OF THE TEAR PRESENTED NO INDICATION OF AN INITIATION POINT OR ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE TEAR. INSPECTION OF THE REMAINDER OF THE DEVICE REVEALED NO OTHER DAMAGE OR IRREGULARITIES. THE MANUFACTURING RECORDS WERE REVIEWED AND CONFIRMED THAT NO ISSUES OR DISCREPANCIES OCCURRED DURING PRODUCTION OF THIS BATCH THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THIS RECORDS REVIEW INDICATES THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS PRIOR TO SHIPMENT. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED OPERATIONAL CONTEXT AS THE DEVICE MET SPECIFICATIONS BUT PERFORMANCE WAS LIMITED BY INTERACTION WITH OTHER DEVICES, INTERACTION WITH PATIENT ANATOMY OR OTHER PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 80% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS SHUNTED LEFT BRACHIUM CEPHALIC VEIN. THE 5.0MM X 40MM STERLING OVER-THE-WIRE BALLOON WAS ADVANCED TO THE LESION FOR TREATMENT AND THE BALLOON RUPTURED AT 10ATMS ON THE FIRST INFLATION. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT WITHOUT INCIDENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 5.0MM X 20MM STERLING BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939032504040 13034542

    Patients

    Seq Age Sex Outcome Treatment
    1 INFLATION DEVICE: EVEREST| GUIDE WIRE: TRANSEND 018/135CM| INTRODUCER SHEATH: MOSQUITO 4F 3CM