BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM? MAVERICK?

    MDR report key: 4093310 · Received September 16, 2014

    Report

    Report Number
    2134265-2014-05506
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 19, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A QUANTUM MAVERICK BALLOON CATHETER IN TWO PIECES. THERE WAS CONTRAST IN THE INFLATION LUMEN AND BLOOD IN BETWEEN THE BALLOON FOLDS. THE BALLOON WAS TIGHTLY FOLDED. MICROSCOPIC EXAMINATION AND TACTILE INSPECTION REVEALED NUMEROUS KINKS THROUGHOUT THE HYPOTUBE OF THE DEVICE. MICROSCOPIC EXAMINATION ALSO REVEALED A COMPLETE HYPOTUBE SEPARATION 69CM FROM THE STRAIN RELIEF. THE HYPOTUBE FRACTURE SURFACES WERE OVALED, WHICH SUGGESTS THE DEVICE WAS KINKED PRIOR TO SEPARATION. MICROSCOPIC EXAMINATION PRESENTED NO DAMAGE OR IRREGULARITIES IN THE BALLOON MATERIAL. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES. DEVICE ANALYSIS DETERMINED THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT INCIDENT. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. 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 OCCURRED. THE 90% STENOSED, 15MM X 4.0MM, ECCENTRIC AND DE NOVO TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED RIGHT CORONARY ARTERY. FOLLOWING PREDILATION WITH AN UNSPECIFIED BALLOON CATHETER, AN UNSPECIFIED STENT WAS DEPLOYED TO TREAT THE TARGET LESION. SUBSEQUENTLY, A 4.0MM X 8MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER WAS SELECTED FOR USE AND ADVANCED TO POSTDILATE THE LESION. HOWEVER, UPON PUSHING THE BALLOON CATHETER, THE SHAFT WAS NOTICED TO BE BROKEN (ABOUT 80CM FROM THE HUB). THE PHYSICIAN WITHDREW THE DEVICE TOGETHER WITH THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED, 15MM X 4.0MM, ECCENTRIC AND DE NOVO TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED RIGHT CORONARY ARTERY. FOLLOWING PREDILATION WITH AN UNSPECIFIED BALLOON CATHETER, AN UNSPECIFIED STENT WAS DEPLOYED TO TREAT THE TARGET LESION. SUBSEQUENTLY, A 4.0MM X 8MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER WAS SELECTED FOR USE AND ADVANCED TO POSTDILATE THE LESION. HOWEVER, UPON PUSHING THE BALLOON CATHETER, THE SHAFT WAS NOTICED TO BE BROKEN (ABOUT 80CM FROM THE HUB). THE PHYSICIAN WITHDREW THE DEVICE TOGETHER WITH THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571182 QUANTUM? MAVERICK? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493808008400 16906324

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR