BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MACH1 GUIDE CATHETER

    MDR report key: 3964740 · Received July 29, 2014

    Report

    Report Number
    2134265-2014-04502
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    April 18, 2014
    Report Date
    July 7, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K020028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER: EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE SHAFT WAS KINKED 1CM FROM THE STRAIN RELIEF AND 2.5CM FROM THE DISTAL TIP. THE KINK NEAR THE TIP WAS ALIGNED WITH A SIDEHOLE. A SHORT LENGTH OF BRAID PROTRUDED FROM THE SIDEHOLE. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES. 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

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT A SHAFT KINK OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN A MODERATELY TORTUOUS AND NON CALCIFIED VESSEL. THE PHYSICIAN ATTEMPTED TO ENGAGE A 7F ART3.5 SH MACH1 GUIDE CATHETER BUT THE DEVICE GOT KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS GOOD. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BRAID PROTRUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442098 MACH1 GUIDE CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H749343574990 0050590566

    Patients

    Seq Age Sex Outcome Treatment
    1