BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX PUSH OVER-THE-WIRE

    MDR report key: 1822410 · Received September 1, 2010

    Report

    Report Number
    2134265-2010-03948
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE RETURNED TO MFR: THE COMPLAINT DEVICE WAS RETURNED WITH A GUIDE WIRE STUCK IN THE WIRE LUMEN. THE GUIDE WIRE WAS UNABLE TO BE REMOVED FROM THE BALLOON CATHETER WITH MINIMAL FORCE. THE BALLOON CATHETER WAS INSPECTED WITH THE GUIDE WIRE STUCK IN THE WIRE LUMEN. MICROSCOPIC INSPECTION REVEALED THE STRAIN RELIEF AND OUTER AND INNER SHAFT COMPONENTS WERE DAMAGED AND THE BALLOON WAS BUNCHED UP. THE DEVICE PRESENTED NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT OR THE DAMAGE TO THE DEVICE. SUBSEQUENTLY THE BALLOON CATHETER SHEATH WAS CUT IN THE INVESTIGATION, TO REMOVE THE GUIDE WIRE. 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

    SAME CASE AS MFR#: 2134265-2010-03977. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THE BALLOON CATHETER BECAME STUCK ON THE GUIDE WIRE. THE TARGET LESION WAS LOCATED IN AN UNSPECIFIED VESSEL. AN UNKNOWN CHOICE FLOPPY GUIDE WIRE WAS PLACED AND AN 8MM X 1.50MM APEX PUSH BALLOON CATHETER WAS LOADED ONTO THE WIRE. WHILE ATTEMPTING TO ADVANCE THE BALLOON, IT BECAME STUCK ON THE WIRE. THE DEVICES WERE REMOVED TOGETHER AS A UNIT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    SAME CASE AS MFR#: 2134265-2010-03977. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THE BALLOON CATHETER BECAME STUCK ON THE GUIDE WIRE. THE TARGET LESION WAS LOCATED IN AN UNSPECIFIED VESSEL. AN UNKNOWN CHOICE FLOPPY GUIDE WIRE WAS PLACED AND AN 8MM X 1.50MM APEX PUSH BALLOON CATHETER WAS LOADED ONTO THE WIRE. WHILE ATTEMPTING TO ADVANCE THE BALLOON, IT BECAME STUCK ON THE WIRE. THE DEVICES WERE REMOVED TOGETHER AS A UNIT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX PUSH OVER-THE-WIRE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493896008150 12632497

    Patients

    Seq Age Sex Outcome Treatment
    1 CHOICE FLOPPY GUIDE WIRE