BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX PTCA DILATATION CATHETER

    MDR report key: 2061416 · Received April 18, 2011

    Report

    Report Number
    2134265-2011-01170
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE NC QUANTUM APEX MONORAIL (MR) DEVICE WAS RECEIVED WITH NO OTHER DEVICES OR ORIGINAL PACKAGING. THERE WAS BLOOD AND CONTRAST IN THE BALLOON AND INFLATION LUMEN. THE BALLOON WAS IN A DEFLATED STATE. THERE WAS A PINHOLE IN THE BALLOON WALL MATERIAL 3MM DISTALLY FROM PROXIMAL BALLOON WAIST. MICROSCOPIC INSPECTION OF THE BALLOON MATERIAL AND THE REMAINDER OF THE DEVICE REVEALED NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE DAMAGED BALLOON. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. 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).

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. AN NC QUANTUM APEX MR 8MM X 2.50MM BALLOON CATHETER WAS SELECTED AND ADVANCED TO TREAT THE TARGET LESION. THE BALLOON WAS INFLATED ONCE TO 18 ATMS AND BURST. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. AN NC QUANTUM APEX MR 8MM X 2.50MM BALLOON CATHETER WAS SELECTED AND ADVANCED TO TREAT THE TARGET LESION. THE BALLOON WAS INFLATED ONCE TO 18 ATMS AND BURST. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    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 H7493912408250 13802097

    Patients

    Seq Age Sex Outcome Treatment
    1