BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING ES PTA BALLOON DILATATION CATHETER

    MDR report key: 2061566 · Received April 18, 2011

    Report

    Report Number
    2134265-2011-01159
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K080982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: RETURNED PRODUCT CONSISTED OF A STERLING ES BALLOON CATHETER WITH NO OTHER DEVICES. VISUAL AND MICROSCOPIC ANALYSIS REVEALED DRIED BLOOD AND CONTRAST WERE PRESENT IN THE SHAFT AND BALLOON. THE BALLOON CATHETER WAS RETURNED IN A DEFLATED STATE. THE BALLOON WAS INSPECTED UNDER MAGNIFICATION TO LOCATE THE BALLOON DEFECT. A PINHOLE AND SCRATCHES WERE CONFIRMED IN THE BALLOON WALL LOCATED 5 MM FROM THE TIP. INSPECTION OF THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL AND THE RO MARKERS THAT COULD HAVE CONTRIBUTED TO THE PINHOLE AND SCRATCHES. THE DISTAL TIP WAS DAMAGED. THE RETURNED DEVICE IS RELATIVELY CONSISTENT WITH THE REPORTED BALLOON BURST; HOWEVER, THERE IS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. 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 PERIPHERAL INTERVENTION PROCEDURE A BALLOON RUPTURE OCCURRED. THE 100% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR TIBIAL ARTERY (ATA). THE 2MM X 40MM X 144CM STERLING ES BALLOON CATHETER WAS ADVANCED FOR PRE DILATION. HOWEVER, DURING THE FIRST INFLATION THE PRESSURE WOULD NOT INCREASE AND A BALLOON RUPTURE OCCURRED. RESIDUAL STENOSIS WAS 100%. THE BALLOON CATHETER WAS REMOVED INTACT AND THE POST DILATION WAS COMPLETED WITH A NON BSC 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 PERIPHERAL INTERVENTION PROCEDURE A BALLOON RUPTURE OCCURRED. THE 100% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR TIBIAL ARTERY (ATA). THE 2MM X 40MM X 144CM STERLING ES BALLOON CATHETER WAS ADVANCED FOR PRE DILATION. HOWEVER, DURING THE FIRST INFLATION THE PRESSURE WOULD NOT INCREASE AND A BALLOON RUPTURE OCCURRED. RESIDUAL STENOSIS WAS 100%. THE BALLOON CATHETER WAS REMOVED INTACT AND THE POST DILATION WAS COMPLETED WITH A NON BSC 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 ES PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939134204010 13582201

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE: CRUISE, ASTATO XS| INTRODUCER SHEATH: PARENT 5F| INFLATION DEVICE: ENCORE| INTRODUCER SHEATH: PARENT 4F