BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2CM PERIPHERAL CUTTING BALLOON®

    MDR report key: 3222583 · Received July 12, 2013

    Report

    Report Number
    2134265-2013-04815
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K070951
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED FOR EVALUATION. A 7FR INTRODUCER SHEATH WAS RETURNED WITH THE COMPLAINT DEVICE. THE SHEATH WAS SPLIT FOR 8.2CM FROM THE DISTAL TIP AND A KINK WAS NOTED AT APPROXIMATELY 8CM FROM THE TIP. A VISUAL EXAMINATION OF THE RETURNED CATHETER SHOWED THE OUTER/INFLATION LUMEN WAS STRETCHED DOWN AT 45CM TO 48CM FROM THE CATHETER TIP. THE SHAFT WAS ALSO SEVERELY KINKED AT 61CM FROM THE STRAIN RELIEF. CONTRAST MEDIA WAS PRESENT THROUGHOUT THE BALLOON AND INFLATION LUMEN. AN ATTEMPT TO INFLATE THE BALLOON WAS UNSUCCESSFUL. THE DEVICE WAS SOAKED IN A WATER TO SOFTEN THE CONTRAST MEDIA; HOWEVER, SUBSEQUENT ATTEMPTS TO INFLATE THE BALLOON WERE UNSUCCESSFUL DUE TO THE SEVERE KINK AND STRETCHING DOWN OF THE INFLATION LUMEN. A VISUAL EXAMINATION CONFIRMED THAT A SECTION OF A BLADE WAS EXPOSED I.E. NOT PROTECTED/COVERED BY THE BALLOON REFOLDS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL INTERVENTION TREATMENT PROCEDURE, REMOVAL DIFFICULTIES AND BLEEDING OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). A 6.00/2.0CM2135CM OTW PERIPHERAL CUTTING BALLOON CATHETER WAS SELECTED TO TREAT THE TARGET LESION. THE DEVICE WAS INFLATED WITH NO ISSUE. THE BALLOON WAS FULLY DEFLATED TO FACILITATE REMOVAL OF THE DEVICE. UPON REMOVAL, RESISTANCE WAS ENCOUNTERED WHILE REMOVING THROUGH THE NON-BSC INTRODUCER SHEATH. IT WAS ALSO NOTED THAT THE BALLOON DID NOT REWRAP PROPERLY CAUSING THE BLADE TO SLICE THE SHEATH AND POSSIBLY PART OF THE VESSEL. NO VISIBLE PERFORATION WAS NOTED, YET BLOOD WAS PRESENT. PRESSURE WAS THEN APPLIED TO STOP THE BLEEDING. THE BLADE WAS NEITHER DETACHED NOR LIFTED. THE PATIENT SUFFERED NO ADVERSE EFFECTS FROM THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL INTERVENTION TREATMENT PROCEDURE, REMOVAL DIFFICULTIES AND BLEEDING OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). A 6.00/2.0CM2135CM OTW PERIPHERAL CUTTING BALLOON CATHETER WAS SELECTED TO TREAT THE TARGET LESION. THE DEVICE WAS INFLATED WITH NO ISSUE. THE BALLOON WAS FULLY DEFLATED TO FACILITATE REMOVAL OF THE DEVICE. UPON REMOVAL, RESISTANCE WAS ENCOUNTERED WHILE REMOVING THROUGH THE NON-BSC INTRODUCER SHEATH. IT WAS ALSO NOTED THAT THE BALLOON DID NOT REWRAP PROPERLY CAUSING THE BLADE TO SLICE THE SHEATH AND POSSIBLY PART OF THE VESSEL. NO VISIBLE PERFORATION WAS NOTED, YET BLOOD WAS PRESENT. PRESSURE WAS THEN APPLIED TO STOP THE BLEEDING. THE BLADE WAS NEITHER DETACHED NOR LIFTED. THE PATIENT SUFFERED NO ADVERSE EFFECTS FROM THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324297 2CM PERIPHERAL CUTTING BALLOON® CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA LIT BOSTON SCIENTIFIC - GALWAY M001PCB60201350

    Patients

    Seq Age Sex Outcome Treatment
    1 Other