BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL PERIPHERAL CUTTING BALLOON®

    MDR report key: 3032586 · Received April 3, 2013

    Report

    Report Number
    2134265-2013-01901
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    March 5, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED WITHOUT THE BALLOON OR TIP. THE DISTAL SECTION OF THE CATHETER HAD DETACHED APPROXIMATELY 134.5CM FROM THE STRAIN RELIEF. THE BALLOON AND TIP HAD DETACHED. TWO MARKERBANDS REMAINED ON THE INNER SHAFT. THE BALLOON PROTECTOR WAS RETURNED HOWEVER THERE WAS NO BALLOON RETURNED. THERE WERE NO ISSUES WITH THE BALLOON PROTECTOR. NO KINKS OR DAMAGE WERE NOTED ALONG THE 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 FISTULAGRAM, BALLOON DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN AN UNKNOWN VESSEL IN THE ARM. THE 4.00MM X 1.5CM X 140CM FLEXTOME PERIPHERAL CUTTING BALLOON WAS BEING PREPARED FOR THE PROCEDURE. DIFFICULTY REMOVING THE BALLOON PROTECTOR WAS EXPERIENCED AND THE BALLOON BECAME STUCK INSIDE THE PROTECTOR. WHEN THE PROTECTOR WAS REMOVED THE BALLOON WAS DETACHED FROM THE DEVICE. THE EVENT OCCURRED DURING PREPARATION, OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A FISTULOGRAM, BALLOON DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN AN UNKNOWN VESSEL IN THE ARM. THE 4.00MM X 1.5CM X 140CM FLEXTOME PERIPHERAL CUTTING BALLOON WAS BEING PREPARED FOR THE PROCEDURE. DIFFICULTY REMOVING THE BALLOON PROTECTOR WAS EXPERIENCED AND THE BALLOON BECAME STUCK INSIDE THE PROTECTOR. WHEN THE PROTECTOR WAS REMOVED THE BALLOON WAS DETACHED FROM THE DEVICE. THE EVENT OCCURRED DURING PREPARATION, OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135724 SMALL PERIPHERAL CUTTING BALLOON® CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY M001PCBO4015140F0 15536051

    Patients

    Seq Age Sex Outcome Treatment
    1