BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL PERIPHERAL CUTTING BALLOON?

    MDR report key: 3202543 · Received July 2, 2013

    Report

    Report Number
    2134265-2013-04615
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 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

    DEVICE EVALUATED BY MANUFACTURER: DEVICE WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE RETURNED UNIT CONFIRMED A COMPLETE BALLOON DETACH FROM THE CATHETER AT THE DISTAL AND PROXIMAL BALLOON BONDS. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DEVICE. THE BALLOON PROTECTOR WAS RETURNED SEPARATE TO THE CATHETER. A MICROSCOPIC EXAMINATION OBSERVED NO DAMAGE TO THE TIP OR BLADES. ALL BLADES WERE PRESENT AND FULLY BONDED TO THE BALLOON SURFACE. NO KINKS OR FURTHER DAMAGE WERE NOTED TO 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 USER RELATED AS COMPLAINT INFORMATION STATES THAT THE USER DID NOT REMOVE ALL AIR FROM THE BALLOON PRIOR TO ATTEMPTED BALLOON PROTECTOR REMOVAL. THE DFU STATES 'D. 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, REPEAT STEP D...G. REMOVE THE PERIPHERAL CUTTING BALLOON DEVICE FROM ITS PROTECTIVE RING. DISCARD THE PROTECTIVE RING. USING STRAIGHT FORCE (NOT A TWISTING MOTION), PULL THE PROTECTIVE SHEATH OFF THE BALLOON'. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, BALLOON SEPARATION FROM THE SHAFT OCCURRED. THE TARGET LESION WAS LOCATED IN A SHUNT IN AN UNKNOWN VESSEL. A 4.00 X 5 MM X 140 CM FLEXTOME CUTTING BALLOON CATHETER WAS SELECTED TO TREAT THE TARGET LESION. DURING UNPACKING, NO RESISTANCE WAS ENCOUNTERED WHEN REMOVING THE DEVICE FROM THE PACKAGING HOOP. IT WAS ALSO NOTED THAT NOT ALL AIR WAS REMOVED FROM THE BALLOON. NO RESISTANCE WAS ENCOUNTERED WHEN ATTEMPTING TO REMOVE TO REMOVE THE BALLOON PROTECTOR; HOWEVER, IT WAS THEN NOTED THAT THE BALLOON GOT SEPARATED FROM THE SHAFT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, BALLOON SEPARATION FROM THE SHAFT OCCURRED. THE TARGET LESION WAS LOCATED IN A SHUNT IN AN UNKNOWN VESSEL. A 4.00 X 5 MM X 140 CM FLEXTOME CUTTING BALLOON CATHETER WAS SELECTED TO TREAT THE TARGET LESION. DURING UNPACKING, NO RESISTANCE WAS ENCOUNTERED WHEN REMOVING THE DEVICE FROM THE PACKAGING HOOP. IT WAS ALSO NOTED THAT NOT ALL AIR WAS REMOVED FROM THE BALLOON. NO RESISTANCE WAS ENCOUNTERED WHEN ATTEMPTING TO REMOVE TO REMOVE THE BALLOON PROTECTOR; HOWEVER, IT WAS THEN NOTED THAT THE BALLOON GOT SEPARATED FROM THE SHAFT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302410 SMALL PERIPHERAL CUTTING BALLOON? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY M001BPM4015140F0 15778169

    Patients

    Seq Age Sex Outcome Treatment
    1