BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX PTCA DILATATION CATHETER

    MDR report key: 1982336 · Received February 9, 2011

    Report

    Report Number
    2134265-2011-00124
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 12, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE RETURNED DEVICE WAS RECEIVED WITH AN UNKNOWN GUIDE WIRE. VISUAL INSPECTION REVEALED NUMEROUS BENDS/KINKS ON THE HYPOTUBE. THE OUTER DIAMETER OF THE RETURNED GUIDE WIRE WAS MEASURED IN THREE DIFFERENT LOCATIONS AND NOTED TO BE 0.01324", 0.01392" AND 0.01394". THE GUIDE WIRE WAS INSERTED INTO THE GUIDE WIRE EXIT NOTCH AND TRACKED THROUGH THE LUMEN WITH DIFFICULTY NOTED ON THE PROXIMAL SIDE OF THE PROXIMAL MARKER BAND. MICROSCOPIC INSPECTION REVEALED DAMAGE TO THE SHAFT AND TIP. THE INNER SHAFT WAS DAMAGED AND APPEARED ACCORDIANED/BUNCHED UP. THE SHAFT WAS KINKED 4.5CM DISTALLY FROM THE GUIDE WIRE EXIT NOTCH AND THE TIP WAS DAMAGED. 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 PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THE BALLOON CATHETER BECAME STUCK ON THE GUIDE WIRE. THE TARGET LESION DETAILS ARE UNKNOWN. A NON BSC GUIDE WIRE WAS PLACED IN THE LESION. WHILE ADVANCING THE 15MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER OVER THE WIRE, RESISTANCE WAS ENCOUNTERED. THE BALLOON WAS ABLE TO BE DELIVERED TO THE LESION, BUT THEN BECAME STUCK ON THE GUIDE WIRE. THE TWO DEVICES WERE REMOVED TOGETHER AS A UNIT AND EXCHANGED FOR DIFFERENT DEVICES IN ORDER TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THE BALLOON CATHETER BECAME STUCK ON THE GUIDE WIRE. THE TARGET LESION DETAILS ARE UNKNOWN. A NON BSC GUIDE WIRE WAS PLACED IN THE LESION. WHILE ADVANCING THE 15MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER OVER THE WIRE, RESISTANCE WAS ENCOUNTERED. THE BALLOON WAS ABLE TO BE DELIVERED TO THE LESION, BUT THEN BECAME STUCK ON THE GUIDE WIRE. THE TWO DEVICES WERE REMOVED TOGETHER AS A UNIT AND EXCHANGED FOR DIFFERENT DEVICES IN ORDER TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC QUANTUM APEX PTCA DILATATION CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912415300 13796844

    Patients

    Seq Age Sex Outcome Treatment
    1 LIFELINE WIZARD GUIDE WIRE