BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL PERIPHERAL CUTTING BALLOON?

    MDR report key: 3122411 · Received May 21, 2013

    Report

    Report Number
    2134265-2013-03364
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 20, 2013
    Report Date
    April 23, 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: THE DEVICE WAS RETURNED IN TWO SECTIONS AS A RESULT OF A SHAFT BREAK LOCATED 24.9CM FROM THE CATHETER TIP. STRETCHING WAS EVIDENT AT THE BREAK SITE. THE BALLOON PROTECTOR WAS RETURNED ON THE BALLOON. IT WAS NOT POSSIBLE TO APPLY A VACUUM TO THE BALLOON AS THE SHAFT WAS BROKEN HOWEVER THE BALLOON PROTECTOR WAS REMOVED FROM THE BALLOON WITH SLIGHT RESISTANCE. A VISUAL EXAMINATION CONFIRMED NO DAMAGE TO THE REMAINING CATHETER. A MICROSCOPIC EXAMINATION OF THE TIP, BALLOON, AND BLADES FOUND NO ISSUES. ALL BLADES WERE PRESENT AND FULLY BONDED TO THE BALLOON. 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 THE DFU STATES 'ATTACH SYRINGE TO THE THREE-WAY STOPCOCK ON THE BALLOON LUMEN...DRAW BACK ON THE SYRINGE TO ITS FULL VOLUME DEFLATING THE BALLOON AND DRAWING AIR BUBBLES INTO THE SYRINGE BARREL; TO MAKE CERTAIN THAT ALL AIR IS REMOVED FROM THE BALLOON, REPEAT STEP' ; HOWEVER, THE COMPLAINT REPORTS THAT THE USER DID NOT ATTACH A SYRINGE/INFLATION DEVICE TO THE UNIT PRIOR TO REMOVAL FROM THE PACKAGING HOOP. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREP FOR A VASCULAR DILATATION, THE CATHETER SHAFT DETACHED. A 4.00MM/1.5CM/140 SPCB FLEXTOME MR CUTTING BALLOON CATHETER WAS SELECTED TO TREAT THE TARGET LESION. DURING PREPARATION, THE USER REMOVED THE DEVICE FROM THE HOOP. UPON REMOVAL OF THE BLUE BALLOON PROTECTOR USING A STRAIGHT FORCE, IT WAS NOTED THAT THE SHAFT WAS DETACHED. NO PATIENT COMPLICATIONS WERE NOTED AND PATIENT CONDITION IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREP FOR A VASCULAR DILATATION, THE CATHETER SHAFT DETACHED. A 4.00MM/1.5CM/140 SPCB FLEXTOME MR CUTTING BALLOON CATHETER WAS SELECTED TO TREAT THE TARGET LESION. DURING PREPARATION, THE USER REMOVED THE DEVICE FROM THE HOOP. UPON REMOVAL OF THE BLUE BALLOON PROTECTOR USING A STRAIGHT FORCE, IT WAS NOTED THAT THE SHAFT WAS DETACHED. NO PATIENT COMPLICATIONS WERE NOTED AND PATIENT CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223591 SMALL PERIPHERAL CUTTING BALLOON? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY M001BPM4015140F0 15778169

    Patients

    Seq Age Sex Outcome Treatment
    1