BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX PTCA DILATATION CATHETER

    MDR report key: 1994053 · Received February 16, 2011

    Report

    Report Number
    2134265-2011-00553
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Report Date
    January 17, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS WITHOUT THE GUIDE WIRE USED IN THE PROCEDURE. MICROSCOPIC INSPECTION OF THE COMPLAINT DEVICE REVEALED A SHAFT HOLE/PERFORATION 3CM PROXIMAL FROM THE TIP. EXAMINATION OF THE MATERIAL SURROUNDING THE HOLE DID NOT REVEAL ANY EVIDENCE OF MATERIAL OR MANUFACTURING DEFICIENCIES THAT WOULD HAVE CONTRIBUTED TO THE INCIDENT. THE INNER DIAMETER OF THE TIP WAS MEASURED USING A CALIBRATED PIN GAUGE SET AND MET SPECIFICATIONS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A GUIDE WIRE PERFORATED A BALLOON CATHETER THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN WAS ATTEMPTING TO INTRODUCE THIS 3.00X12MM NC QUANTUM APEX BALLOON CATHETER WHEN THE GUIDE WIRE "DID NOT GO THROUGH THE NORMAL MONORAIL EXIT". THIS OCCURRED PRIOR TO ENTERING THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A GUIDE WIRE PERFORATED A BALLOON CATHETER THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN WAS ATTEMPTING TO INTRODUCE THIS 3.00X12MM NC QUANTUM APEX BALLOON CATHETER WHEN THE GUIDE WIRE "DID NOT GO THROUGH THE NORMAL MONORAIL EXIT". THIS OCCURRED PRIOR TO ENTERING THE PATIENT. NO PATIENT COMPLICATIONS WERE 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 H7493912412300 13962474

    Patients

    Seq Age Sex Outcome Treatment
    1