BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING¿

    MDR report key: 2980755 · Received February 27, 2013

    Report

    Report Number
    2134265-2013-00999
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    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: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS WITH BLOOD IN THE BALLOON AND INFLATION LUMEN. MAGNIFIED INSPECTION REVEALED NO DAMAGE. POSITIVE PRESSURE WAS APPLIED WITH AN INFLATION DEVICE FILLED WITH WATER, AND A STREAM OF WATER EMITTED FROM A PINHOLE IN THE BALLOON WALL 18MM FROM THE PROXIMAL EDGE OF THE DISTAL MARKERBAND. THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL. 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS RIGHT SUPERFICIAL FEMORAL ARTERY. THIS 5.0 X 60/80 (4F) STERLING OTW BALLOON CATHETER WAS ADVANCED AND INFLATED TWICE. THE FIRST INFLATION WAS TO 6ATM AND UPON THE 2ND INFLATION THE BALLOON RUPTURED AT 6ATM. THE PROCEDURE WAS COMPLETED WITH A 5 X 40 STERLING OTW BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS RIGHT SUPERFICIAL FEMORAL ARTERY. THIS 5.0 X 60/80 (4F) STERLING OTW BALLOON CATHETER WAS ADVANCED AND INFLATED TWICE. THE FIRST INFLATION WAS TO 6ATM AND UPON THE 2ND INFLATION THE BALLOON RUPTURED AT 6ATM. THE PROCEDURE WAS COMPLETED WITH A 5 X 40 STERLING OTW 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
    83952 STERLING¿ CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939032506080 15768186

    Patients

    Seq Age Sex Outcome Treatment
    1 INFLATION DEVICE: ENCORE| GUIDE WIRE: CRUISE - ST. JUDE MEDICAL| INTRODUCER SHEATH: 6F TERUMO SHEATH