BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL PERIPHERAL CUTTING BALLOON?

    MDR report key: 3132852 · Received May 29, 2013

    Report

    Report Number
    2134265-2013-03410
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P950020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A VISUAL EXAMINATION CONFIRMED A COMPLETE BALLOON DETACH. THE BALLOON HAD DETACHED FROM THE CATHETER AT THE DISTAL BOND AND THE PROXIMAL BOND. THE DISTAL SECTION OF THE INNER LUMEN WAS STRETCHED WHICH RESULTED IN THE MARKERBANDS MOVING FREELY. THE BALLOON SECTION WAS ANALYZED WHICH IDENTIFIED NO ISSUES WITH THE TIP, BALLOON MATERIAL, OR BLADES. ALL BLADES WERE PRESENT AND FULLY BONDED TO THE BALLOON. THERE WAS NO DAMAGE TO THE REMAINING SHAFT OF THE DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE, BALLOON DETACHMENT OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THERE WAS NO RESISTANCE ENCOUNTERED WHEN REMOVING THE 4.00MM/1.5CM/140CM SMALL PERIPHERAL CUTTING BALLOON DEVICE FROM PACKAGING. THE RESISTANCE WAS ENCOUNTERED UPON REMOVAL OF THE DEVICE FROM ITS PROTECTIVE RING. ALL AIR WAS REMOVED FROM THE BALLOON PRIOR TO ATTEMPTING REMOVAL OF BALLOON PROTECTOR. WHEN THE BALLOON PROTECTOR WAS REMOVED USING A STRAIGHT FORCE, THE BALLOON BECAME DETACHED FROM THE SHAFT. THE DEVICE WAS NOT USED ON THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE, BALLOON DETACHMENT OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THERE WAS NO RESISTANCE ENCOUNTERED WHEN REMOVING THE 4.00MM/1.5CM/140CM SMALL PERIPHERAL CUTTING BALLOON DEVICE FROM PACKAGING. THE RESISTANCE WAS ENCOUNTERED UPON REMOVAL OF THE DEVICE FROM ITS PROTECTIVE RING. ALL AIR WAS REMOVED FROM THE BALLOON PRIOR TO ATTEMPTING REMOVAL OF BALLOON PROTECTOR. WHEN THE BALLOON PROTECTOR WAS REMOVED USING A STRAIGHT FORCE, THE BALLOON BECAME DETACHED FROM THE SHAFT. THE DEVICE WAS NOT USED ON THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234271 SMALL PERIPHERAL CUTTING BALLOON? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY M001BPM4015140F0 15788826

    Patients

    Seq Age Sex Outcome Treatment
    1