BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL PERIPHERAL CUTTING BALLOON?

    MDR report key: 3211238 · Received July 8, 2013

    Report

    Report Number
    2134265-2013-04690
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P950020
    Removal / Correction Number
    90872934-FA
    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

    CORRECTION: DEVICE LOT NUMBER FROM 15824636 TO 0015774378. CORRECTION: DEVICE EXPIRATION DATE FROM 24-JAN-2016 TO 03-JAN-2016. CORRECTION: DEVICE MANUFACTURED DATE FROM 14-FEB-2013 TO 18-JAN-2013. DEVICE EVALUATED BY MFR: THE CATHETER WAS RETURNED IN TWO SECTIONS TO THE COMPLAINT INVESTIGATION SITE AS A RESULT OF A COMPLETE BALLOON DETACH AT THE DISTAL AND PROXIMAL BALLOON BONDS. THE BALLOON PROTECTOR WAS RETURNED SEPARATE TO THE BALLOON. THE INNER LUMEN WAS STRETCHED RESULTING IN THE MARKERBANDS BECOMING LOOSE AND MOVING ON THE INNER LUMEN. THE BALLOON HAD DETACHED APPROXIMATELY 145CM FROM THE CATHETER STRAIN RELIEF. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DEVICE DURING THE REPORTED EVENT OF DIFFICULTIES REMOVING THE PROTECTOR CAP. NO ADDITIONAL DAMAGE WAS NOTED TO THE SHAFT. A MICROSCOPIC EXAMINATION OBSERVED NO DAMAGE TO THE TIP OR BLADES. ALL BLADES WERE PRESENT AND FULLY BONDED TO THE BALLOON SURFACE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION OF A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, A BALLOON SEPARATION OCCURRED. THE TARGET LESION IS LOCATED AT THE SUPERFICIAL FEMORAL ARTERY. A 44.00MM/1.5CM/140CM SMALL PERIPHERAL CUTTING BALLOON FLEXTOME MONORAIL WAS SELECTED TO TREAT THE TARGET LESION. DURING PREPARATION, UPON REMOVAL OF THE BALLOON PROTECTOR THE BALLOON SEPARATED FROM THE SHAFT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE 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 OF A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, A BALLOON SEPARATION OCCURRED. THE TARGET LESION IS LOCATED AT THE SUPERFICIAL FEMORAL ARTERY. A 44.00MM/1.5CM/140CM SMALL PERIPHERAL CUTTING BALLOON FLEXTOME MONORAIL WAS SELECTED TO TREAT THE TARGET LESION. DURING PREPARATION, UPON REMOVAL OF THE BALLOON PROTECTOR THE BALLOON SEPARATED FROM THE SHAFT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE 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
    311135 SMALL PERIPHERAL CUTTING BALLOON? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY M001BPM4015140F0 0015774378

    Patients

    Seq Age Sex Outcome Treatment
    1