BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK BALLOON CATHETER

    MDR report key: 1964500 · Received January 20, 2011

    Report

    Report Number
    2134265-2010-05963
    Event Type
    Malfunction
    Date Received
    January 20, 2011
    Date of Event
    December 28, 2010
    Report Date
    December 29, 2010
    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

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RECEIVED FOR ANALYSIS IN TWO PIECES. A HYPOTUBE FRACTURE WAS IDENTIFIED. THE PROXIMAL PORTION OF THE DEVICE MEASURED 26.5CM FROM THE DISTAL EDGE OF THE STRAIN RELIEF TO THE HYPOTUBE FRACTURE SITE. THE DISTAL PORTION OF THE DEVICE MEASURED 116CM FROM THE HYPOTUBE FRACTURE SITE TO THE DISTAL TIP. THE APPEARANCE OF THE FRACTURE SURFACE IS CONSISTENT WITH THE DEVICE HAVING BEEN KINKED PRIOR TO THE BREAK. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A SHAFT BREAK OCCURRED. THE 3.0X24MM, 90% STENOSED, CONCENTRIC SHAPED, DE-NOVO TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. WHEN THIS 3.0X12MM QUANTUM MAVERICK BALLOON CATHETER WAS REMOVED FROM THE PACKAGING, IT WAS NOTED THAT THE SHAFT WAS BROKEN. THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A SHAFT BREAK OCCURRED. THE 3.0X24MM, 90% STENOSED, CONCENTRIC SHAPED, DE-NOVO TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. WHEN THIS 3.0X12MM QUANTUM MAVERICK BALLOON CATHETER WAS REMOVED FROM THE PACKAGING, IT WAS NOTED THAT THE SHAFT WAS BROKEN. THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM MAVERICK BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493808012300 13469597

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR