BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTUM? MAVERICK?

    MDR report key: 4860186 · Received June 22, 2015

    Report

    Report Number
    2134265-2015-04209
    Event Type
    Injury
    Date Received
    June 22, 2015
    Date of Event
    May 19, 2015
    Report Date
    June 4, 2015
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A QUANTUM MAVERICK BALLOON CATHETER IN 2 PIECES. THE BALLOON WAS TIGHTLY FOLDED. THE HYPOTUBE SHAFT WAS BROKEN 56.5CM FROM THE TIP OF THE DEVICE. THE FRACTURE FACES WERE OVAL AS IF KINKED PRIOR TO SEPARATION. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE DAMAGE. INSPECTION OF THE INNER AND OUTER SHAFTS, THE COREWIRE AND THE REMAINDER OF THE DEVICE PRESENTED NO 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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED, 8X3MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.5MM X 8MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER WAS SELECTED FOR USE AND ADVANCED TO DILATE THE TARGET LESION. INSIDE THE GUIDE CATHETER, THE SHAFT FRACTURED >15CM AWAY FROM THE HUB DURING THE PROCEDURE. ANOTHER BALLOON WAS USED FOR DILATION TO REMOVE THE FRACTURED SHAFT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED, 8X3MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.5MM X 8MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER WAS SELECTED FOR USE AND ADVANCED TO DILATE THE TARGET LESION. INSIDE THE GUIDE CATHETER, THE SHAFT FRACTURED >15CM AWAY FROM THE HUB DURING THE PROCEDURE. ANOTHER BALLOON WAS USED FOR DILATION TO REMOVE THE FRACTURED SHAFT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402910 QUANTUM? MAVERICK? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493808008250 17355041

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention