BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM? MAVERICK?

    MDR report key: 3896813 · Received June 26, 2014

    Report

    Report Number
    2134265-2014-03692
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 31, 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: RETURNED PRODUCT CONSISTED OF A QUANTUM MAVERICK BALLOON CATHETER. THERE WAS BLOOD IN THE WIRE LUMEN. THERE WERE MULTIPLE HYPOTUBE KINKS. 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 NOT CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 20X3.5MM, ECCENTRIC, DE NOVO, 90% STENOSED TARGET LESION WAS LOCATED IN A MILDLY CALCIFIED AND MILDLY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. FOLLOWING A 190CMX0.014" NON-BSC GUIDE WIRE, PREDILATION WAS PERFORMED USING AN UNSPECIFIED BALLOON CATHETER. UNSPECIFIED STENTS WERE IMPLANTED. A 3.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS THEN SELECTED TO POST-DILATE THE TARGET LESION. WHILE ADVANCING THE DEVICE, IT WAS NOTICED THAT THE SHAFT BROKE OFF 20CM AWAY FROM THE HUB . THE PHYSICIAN WITHDREW THE BALLOON TOGETHER WITH THE GUIDE CATHETER AND COMPLETED THE PROCEDURE 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 20X3.5MM, ECCENTRIC, DE NOVO, 90% STENOSED TARGET LESION WAS LOCATED IN A MILDLY CALCIFIED AND MILDLY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. FOLLOWING A 190CMX0.014" NON-BSC GUIDE WIRE, PREDILATION WAS PERFORMED USING AN UNSPECIFIED BALLOON CATHETER. UNSPECIFIED STENTS WERE IMPLANTED. A 3.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS THEN SELECTED TO POST-DILATE THE TARGET LESION. WHILE ADVANCING THE DEVICE, IT WAS NOTICED THAT THE SHAFT BROKE OFF 20CM AWAY FROM THE HUB . THE PHYSICIAN WITHDREW THE BALLOON TOGETHER WITH THE GUIDE CATHETER AND COMPLETED THE PROCEDURE 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
    374568 QUANTUM? MAVERICK? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493808015350 16678362

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR BMW WIRES 190CM 0.014"