BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK²?

    MDR report key: 3932584 · Received July 14, 2014

    Report

    Report Number
    2134265-2014-04175
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A MAVERICK 2 BALLOON CATHETER WITH NO OTHER DEVICES. THERE WAS BLOOD IN THE WIRE LUMEN. THE BALLOON WAS TIGHTLY FOLDED. THERE WAS A COMPLETE HYPOTUBE SEPARATION 83CM FROM THE HUB. THE HYPOTUBE FRACTURE SURFACES WERE OVALED, WHICH SUGGESTS THE DEVICE WAS KINKED PRIOR TO SEPARATION. AN INFLATION DEVICE FILLED WITH WATER WAS CONNECTED TO THE REMAINING DISTAL END OF THE DEVICE BY ATTACHING A TOUGHY AND A STOPCOCK TO THE FRACTURED HYPOTUBE. THE DEVICE WAS INFLATED TO RATED BURST PRESSURE FOR FIVE (5) MINUTES. THE DEVICE MAINTAINED PRESSURE WITH NO INDICATION OF ANY LEAKS OR ANOMALIES. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING 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 SHAFT BREAK AND BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 20MM MAVERICK² BALLOON CATHETER WAS SELECTED FOR USE TO DILATE THE LESION. UPON AN UNKNOWN NUMBER OF INFLATION, THE BALLOON RUPTURED AT 6 ATMOSPHERES AND THE BALLOON CATHETER SHAFT BROKE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHAFT BREAK AND BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 20MM MAVERICK²¿ BALLOON CATHETER WAS SELECTED FOR USE TO DILATE THE LESION. UPON AN UNKNOWN NUMBER OF INFLATION, THE BALLOON RUPTURED AT 6 ATMOSPHERES AND THE BALLOON CATHETER SHAFT BROKE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409232 MAVERICK²? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493892820200 16696229

    Patients

    Seq Age Sex Outcome Treatment
    1