BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL PERIPHERAL CUTTING BALLOON®

    MDR report key: 3103230 · Received May 9, 2013

    Report

    Report Number
    2134265-2013-03327
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K062387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE DEVICE WAS RETURNED IN TWO SECTIONS AS A RESULT OF A BALLOON DETACH. THE BALLOON HAD DETACHED AT BOTH THE DISTAL BOND AND THE PROXIMAL BOND. THE BALLOON PROTECTOR WAS RETURNED OVER THE BALLOON. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE USED DURING ATTEMPTS TO REMOVE THE BALLOON PROTECTOR DURING PREPARATION. THE BALLOON PROTECTOR WAS REMOVED FROM THE BALLOON WITH SLIGHT RESISTANCE AND SUBSEQUENTLY NO ADDITIONAL ISSUES WERE NOTED WITH THE BALLOON OR BLADES. ALL BLADES WERE PRESENT AND FULLY BONDED TO THE BALLOON. A VISUAL EXAMINATION IDENTIFIED A SHAFT KINK APPROXIMATELY 28.6CM FROM THE STRAIN RELIEF, AND COMPRESSION WAS PRESENT PROXIMAL TO THE DETACHED SECTION OF THE SHAFT. SHAFT KINKS AND COMPRESSION ARE CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DEVICE DURING HANDLING/USE. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS USER RELATED AS THE DFU STATES 'DRAW BACK ON THE SYRINGE TO ITS FULL VOLUME DEFLATING THE BALLOON AND DRAWING AIR BUBBLES INTO THE SYRINGE BARREL; E. TO MAKE CERTAIN THAT ALL AIR IS REMOVED FROM THE BALLOON". THE COMPLAINT STATES THAT THE USER DID NOT DRAW BACK ON THE SYRINGE TO ITS FULL VOLUME DEFLATING THE BALLOON DURING PREPARATION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE THE SHAFT OF A SMALL PERIPHERAL CUTTING BALLOON BROKE OFF. ACCESS WAS OBTAINED VIA RIGHT FEMORAL ARTERY ON A 85% STENOSED TARGET LESION WHICH WAS LOCATED IN A MILDLY TORTUOUS AND MILDLY CALCIFIED PROXIMAL PERONEAL AREA. A 4.00MM/1.5CM/140CM SPCB FLEXTOME OTW WAS USED FOR DILATATION OF THE LESION AND UPON INTRODUCTION THE SHAFT OF THE CUTTING BALLOON BROKE OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER SPCB FLEXTOME OTW. PATIENT CONDITION AFTER PROCEDURE WAS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE THE SHAFT OF A SMALL PERIPHERAL CUTTING BALLOON BROKE OFF. ACCESS WAS OBTAINED VIA RIGHT FEMORAL ARTERY ON A 85% STENOSED TARGET LESION WHICH WAS LOCATED IN A MILDLY TORTUOUS AND MILDLY CALCIFIED PROXIMAL PERONIAL AREA. A 4.00MM/1.5CM/140CM SPCB FLEXTOME OTW WAS USED FOR DILATATION OF THE LESION AND UPON INTRODUCTION THE SHAFT OF THE CUTTING BALLOON BROKE OFF.. THE PROCEDURE WAS COMPLETED WITH ANOTHER SPCB FLEXTOME OTW. PATIENT CONDITION AFTER PROCEDURE WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203458 SMALL PERIPHERAL CUTTING BALLOON® CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY M001PCBO4015140F0

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR