BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX?

    MDR report key: 3952249 · Received July 23, 2014

    Report

    Report Number
    2134265-2014-04254
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 27, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF AN APEX BALLOON CATHETER WITH NO OTHER DEVICES. THERE WAS BLOOD IN THE INFLATION LUMEN AND CONTRAST ON THE DISTAL TIP. MAGNIFIED INSPECTION IDENTIFIED A LONGITUDINAL TEAR EXTENDING THE FULL LENGTH OF THE BALLOON. NO OTHER DAMAGE OR IRREGULARITIES WERE NOTED IN THE BALLOON AND PROXIMAL BOND. MICROSCOPIC EXAMINATION PRESENTED NO IRREGULARITIES IN THE MARKER BANDS 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY CALCIFIED AND MILDLY TORTUOUS UNSPECIFIED LOCATION. A 2.75MM X 20MM APEX¿ BALLOON CATHETER WAS ADVANCED FOR DILATATION AND WAS INITIALLY INFLATED AT 10 ATMOSPHERES FOR 15 SECONDS. HOWEVER, ON THE SECOND INFLATION AT 10 ATMOSPHERES FOR 8 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY WITHOUT ANY INCIDENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.75MM X 20MM APEX¿ BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY CALCIFIED AND MILDLY TORTUOUS UNSPECIFIED LOCATION. A 2.75MM X 20MM APEX¿ BALLOON CATHETER WAS ADVANCED FOR DILATATION AND WAS INITIALLY INFLATED AT 10 ATMOSPHERES FOR 15 SECONDS. HOWEVER, ON THE SECOND INFLATION AT 10 ATMOSPHERES FOR 8 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY WITHOUT ANY INCIDENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.75MM X 20MM APEX¿ BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430471 APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493895920270 15941232

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR