BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING ES PTA BALLOON DILATATION CATHETER

    MDR report key: 1832468 · Received September 13, 2010

    Report

    Report Number
    2134265-2010-04103
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 26, 2010
    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

    DEVICE EVALUATED BY MANUFACTURER: RETURNED PRODUCT CONSISTED OF AN OVER-THE-WIRE STERLING ES BALLOON CATHETER. VISUAL ANALYSIS REVEALED DRIED BLOOD AND CONTRAST WERE PRESENT IN THE SHAFT AND BALLOON. THE BALLOON CATHETER WAS RETURNED IN A DEFLATED STATE. MICROSCOPIC ANALYSIS REVEALED A PINHOLE AND SCRATCHES IN THE BALLOON WALL LOCATED 25 MM FROM THE TIP AND THE DISTAL TIP WAS DAMAGED. INSPECTION OF THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL AND THE RO MARKERS THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. 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

    (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 WITH AN IPSOLATERAL APPROACH FROM THE FEMORAL ARTERY. THE 99% STENOSED LESION WAS LOCATED IN A CALCIFIED AND SEVERELY TORTUOUS VESSEL BELOW THE LEFT KNEE. A 2MM X 20MM X 142CM STERLING ES PTA BALLOON DILATATION CATHETER WAS SELECTED FOR PRE DILATION AND DURING ADVANCEMENT THROUGH THE CALCIFIED VESSEL SLIGHT RESISTANCE WAS ENCOUNTERED. ON THE FIRST INFLATION TO 4 ATMS FOR APPROXIMATELY 5 SECONDS, A BALLOON RUPTURE OCCURRED. THE BALLOON CATHETER WAS REMOVED AND 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 TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED WITH AN IPSOLATERAL APPROACH FROM THE FEMORAL ARTERY. THE 99% STENOSED LESION WAS LOCATED IN A CALCIFIED AND SEVERELY TORTUOUS VESSEL BELOW THE LEFT KNEE. A 2MM X 20MM X 142CM STERLING ES PTA BALLOON DILATATION CATHETER WAS SELECTED FOR PRE DILATION AND DURING ADVANCEMENT THROUGH THE CALCIFIED VESSEL SLIGHT RESISTANCE WAS ENCOUNTERED. ON THE FIRST INFLATION TO 4 ATMS FOR APPROXIMATELY 5 SECONDS, A BALLOON RUPTURE OCCURRED. THE BALLOON CATHETER WAS REMOVED AND 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 ES PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939134202010 12229835

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH:TERUMO 4F| INFLATION DEVICE: JMS| GUDE WIRE: RUBY INTERMEDIATE