BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK 2 (TM)

    MDR report key: 2211242 · Received August 15, 2011

    Report

    Report Number
    2134265-2011-03326
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Report Date
    July 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. AN EXAMINATION OF THE RETURNED DEVICE FOUND COMPLETE SEPARATION OF THE HYPOTUBE. THE HYPOTUBE SEPARATION WAS 63CM FROM THE STRAIN RELIEF AND 79CM FROM THE DISTAL TIP. THE HYPOTUBE WAS BENT NEAR THE SEPARATION AND THE FRACTURE SURFACES WERE OVALED, WHICH SUGGESTS THE DEVICE WAS KINKED PRIOR TO SEPARATION. THERE WAS NO EVIDENCE OF BLOOD OR CONTRAST IN THE DEVICE. THE BALLOON WAS TIGHTLY FOLDED. A THOROUGH INSPECTION OF THE REMAINDER OF THE DEVICE REVEALED 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

    DEVICE EVALUATED BY MANUFACTURER: 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 TREATMENT PROCEDURE, A SHAFT FRACTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 95% RESTENOSED TARGET LESION WAS SEVERELY CALCIFIED AND SEVERALLY TORTUOUS AND 20MM IN LENGTH. THE VESSEL DIAMETER WAS 3.0MM WITH A SIGNIFICANT BEND IN THE LESION GREATER OR EQUAL TO 90 DEGREES. THE LESION SHAPE WAS CONCENTRIC. THE 12MMX2.0MM MAVERICK 2 MONORAIL BALLOON CATHETER WAS USED DURING PROCEDURE AND THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAVERICK 2 MONORAIL BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TREATMENT PROCEDURE, A SHAFT FRACTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 95% RESTENOSED TARGET LESION WAS SEVERELY CALCIFIED AND SEVERALLY TORTUOUS AND 20MM IN LENGTH. THE VESSEL DIAMETER WAS 3.0MM WITH A SIGNIFICANT BEND IN THE LESION GREATER OR EQUAL TO 90 DEGREES. THE LESION SHAPE WAS CONCENTRIC. THE 12MMX2.0MM MAVERICK 2 MONORAIL BALLOON CATHETER WAS USED DURING PROCEDURE AND THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAVERICK 2 MONORAIL BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK 2 (TM) CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493892812200 14196499

    Patients

    Seq Age Sex Outcome Treatment
    1