BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL PERIPHERAL CUTTING BALLOON?

    MDR report key: 3131875 · Received May 29, 2013

    Report

    Report Number
    2134265-2013-03645
    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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE HYPOTUBE WAS KINKED. THE KINK WAS LOCATED AT 12.2CM DISTAL TO THE STRAIN RELIEF. AN EXAMINATION OF THE BALLOON AND BLADES FOUND NO ANOMALIES. USING AN ENCORE INFLATION UNIT THE BALLOON WAS INFLATED TO ITS RATED BURST PRESSURE (RBP) OF 12 ATMOSPHERES WITH NO LEAKS OR RESTRICTIONS. A VACUUM WAS PULLED AND THE BALLOON DEFLATED IN 2 SECONDS. THIS PROCESS OF INFLATION TO RBP AND DEFLATING THE BALLOON WAS REPEATED FOUR MORE TIMES AND ON EACH OCCASION THE BALLOON DEFLATED IN 2 SECONDS. NO OTHER DAMAGE TO THE DEVICE WAS NOTED. 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 A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY THE BALLOON WAS SLOW TO DEFLATE. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE MODERATELY TORTUOUS LEFT CEPHALIC VEIN. A 4.00MM/1.5CM/140CM SPCB FLEXTOME MR CUTTING BALLOON CATHETER WAS SELECTED TO TREAT THE LESION. UPON UNPACKING, THEY NOTICED THAT THE SHAFT OF THE HYPOTUBE WAS KINKED; HOWEVER, THE PHYSICIAN ELECTED TO STILL USE THE DEVICE. THE DEVICE WAS INSERTED INTO THE SHEATH AND ADDED PRESSURE. THE CUTTING BALLOON TOOK TIME TO BE INFLATED AND DEFLATED. THE DEVICE WAS EXCHANGED WITH A MUSTANG 5.0*40 TO COMPLETE THE PROCEDURE. 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 THE BALLOON WAS SLOW TO DEFLATE. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE MODERATELY TORTUOUS LEFT CEPHALIC VEIN. A 4.00MM/1.5CM/140CM SPCB FLEXTOME MR CUTTING BALLOON CATHETER WAS SELECTED TO TREAT THE LESION. UPON UNPACKING, THEY NOTICED THAT THE SHAFT OF THE HYPOTUBE WAS KINKED; HOWEVER, THE PHYSICIAN ELECTED TO STILL USE THE DEVICE. THE DEVICE WAS INSERTED INTO THE SHEATH AND ADDED PRESSURE. THE CUTTING BALLOON TOOK TIME TO BE INFLATED AND DEFLATED. THE DEVICE WAS EXCHANGED WITH A MUSTANG 5.0.40 TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235870 SMALL PERIPHERAL CUTTING BALLOON? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY M001BPM4015140F0 0015659217

    Patients

    Seq Age Sex Outcome Treatment
    1