BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING SL BALLOON DILATATION CATHETER

    MDR report key: 1982231 · Received February 9, 2011

    Report

    Report Number
    2134265-2011-00131
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 13, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K093720
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE RETURNED PRODUCT CONSISTED OF A MONORAIL STERLING BALLOON CATHETER WITH NO ORIGINAL PACKAGING OR OTHER DEVICES. THERE WAS A BLOOD-LIKE SUBSTANCE IN THE BALLOON. MAGNIFIED INSPECTION OF THE DISTAL END OF THE DEVICE REVEALED THAT THE TIP WAS DAMAGED. THE DEVICE WAS PREPPED ACCORDING TO THE DFU, AND A NEW INFLATION DEVICE FILLED WITH WATER WAS CONNECTED TO THE INFLATION PORT TO INFLATE THE DEVICE. WHEN POSITIVE PRESSURE WAS APPLIED WITH THE INFLATION DEVICE A STREAM OF WATER EMITTED FROM TWO HOLES IN THE BALLOON MATERIAL, ONE HOLE WAS NEAR THE MIDDLE OF THE DISTAL MARKERBAND AND THE OTHER WAS < 1 MM FROM THE PROXIMAL END OF THE DISTAL MARKERBAND. INSPECTION OF THE BALLOON MATERIAL IN THE AREA OF THE HOLE PRESENTED NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE REPORTED EVENT OR THE CONFIRMED DAMAGE TO THE DEVICE. THE TIP WAS DAMAGED. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE TIP DAMAGE. INSPECTION OF THE REMAINDER OF THE DEVICE REVEALED NO OTHER DAMAGE OR IRREGULARITIES. 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

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE A BALLOON RUPTURE OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN A MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY. WHILE ATTEMPTING TO PULL NEGATIVE PRESSURE ON THE STERLING SL MR 4 X 120 X 150 BALLOON DURING THE FIRST INFLATION, BLOOD "FLEW" BACK. IT WAS NOTED THAT DURING ADVANCEMENT OF THE DEVICE THE BALLOON "COULD HAVE BEEN RUPTURED". THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 PROCEDURE A BALLOON RUPTURE OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN A MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY. WHILE ATTEMPTING TO PULL NEGATIVE PRESSURE ON THE STERLING SL MR 4 X 120 X 150 BALLOON DURING THE FIRST INFLATION, BLOOD "FLEW" BACK. IT WAS NOTED THAT DURING ADVANCEMENT OF THE DEVICE THE BALLOON "COULD HAVE BEEN RUPTURED". THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 SL BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939147401210 13786063

    Patients

    Seq Age Sex Outcome Treatment
    1