BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING ES PTA BALLOON DILATATION CATHETER

    MDR report key: 1945484 · Received January 4, 2011

    Report

    Report Number
    2134265-2010-05673
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K080982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER: RETURNED PRODUCT CONSISTED OF AN OVER-THE-WIRE (OTW) STERLING ES BALLOON CATHETER WITH NO ORIGINAL PACKAGING OR OTHER DEVICES. THERE WAS A BLOOD LIKE SUBSTANCE ON THE OUTER SURFACES OF THE DEVICE. THE BALLOON WAS TORN LONGITUDINALLY 7 - 45 MM FROM THE TIP. THERE WERE KINKS IN THE INNER SHAFT 11, 12, 15, AND 45 MM FROM THE TIP AND A HOLE IN THE INNER SHAFT 35 MM FROM THE TIP. THE DEVICE PRESENTED NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE REPORTED EVENT. THE DAMAGE TO THE INNER SHAFT OF BOTH DEVICES COULD NOT OCCUR WITH A GUIDE WIRE IN THE WIRE LUMEN, WHICH SUGGESTS THE DAMAGE OCCURRED WITHOUT THE DEVICE FULLY LOADED OVER A GUIDE WIRE. 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).

    Description of Event or Problem · 1

    SAME CASE AS MFR#: 2134265-2010-05672. IT WAS REPORTED THAT DURING AN UNSPECIFIED TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. THE 95-100% STENOSED LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED DISTAL ANTERIOR TIBIAL ARTERY AND DORSAL PEDALIS ARTERY. THE STERLING ES OTW 2MM X 40MM X 144CM BALLOON WAS INFLATED TO RATED BURST PRESSURE AND RUPTURED. IT WAS REMOVED INTACT AND THE SHAFT WAS FOUND KINKED. THE PHYSICIAN ATTEMPTED TREATMENT WITH ANOTHER STERLING ES OTW 2MM X 40MM X 144CM AND THIS BALLOON RUPTURED AT RATED BURST PRESSURE AND THE SHAFT WAS KINKED AS WELL. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH A SYMMETRY BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING ES PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939134204010 13860404

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR TRANSEND GUIDE WIRE| JOURNEY GUIDE WIRE| 2.0X40MM STERLING ES BALLOON