BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX¿

    MDR report key: 2992918 · Received March 7, 2013

    Report

    Report Number
    2134265-2013-01287
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 12, 2013
    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: 18 YEARS OR OLDER. (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).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: MAGNIFIED INSPECTION REVEALED NO DAMAGE. WHEN POSITIVE PRESSURE WAS APPLIED WITH AN INFLATION DEVICE FILLED WITH WATER, A STREAM OF WATER EMITTED FROM A PINHOLE IN THE BALLOON WALL ADJACENT TO THE DISTAL END OF THE PROXIMAL BALLOON BOND. THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKER THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. 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 TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. THE 100% STENOSED LESION WAS LOCATED IN A SEVERELY TORTUOUS AND CALCIFIED ANTIVENTRICULAR OF THE RIGHT CORONARY ARTERY. THE APEX OTW, 2.50MM X 8MM CROSSED THE LESION. THE BALLOON WAS INFLATED AND RUPTURED. THE NUMBER OF INFLATIONS IS UNKNOWN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. THE 100% STENOSED LESION WAS LOCATED IN A SEVERELY TORTUOUS AND CALCIFIED ANTIVENTRICULAR OF THE RIGHT CORONARY ARTERY. THE APEX OTW, 2.50MM X 8MM CROSSED THE LESION. THE BALLOON WAS INFLATED AND RUPTURED. THE NUMBER OF INFLATIONS IS UNKNOWN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96765 APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493895808250 14460018

    Patients

    Seq Age Sex Outcome Treatment
    1