BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE¿

    MDR report key: 2830311 · Received November 13, 2012

    Report

    Report Number
    2134265-2012-06978
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 17, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K113220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: EXAMINATION OF THE RETURNED DEVICE REVEALED THE CATHETER WAS INSIDE A CARRIER TUBE WITH A MANDREL AND BALLOON PROTECTOR IN THE AS-MANUFACTURED POSITION ON THE CATHETER. THERE WAS A COMPLETE SEPARATION OF THE HYPOTUBE 51CM FROM THE DISTAL TIP. THE HYPOTUBE FRACTURE SURFACES WERE OVALED INDICATING THE DEVICE WAS LIKELY KINKED PRIOR TO SEPARATION. THERE WAS NO EVIDENCE THAT THE SEPARATION WAS ATTRIBUTABLE TO ANY PRODUCT QUALITY DEFICIENCIES. 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 DURING A PERCUTANEOUS CORONARY INTERVENTION, A CATHETER BREAK OCCURRED. THE TARGET LESION DETAILS ARE UNKNOWN. WHILE ADVANCING THE 3.0 X 15 MM EMERGE BALLOON CATHETER INSIDE THE PATIENT, THE CATHETER "SNAPPED". THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A CATHETER BREAK OCCURRED. THE TARGET LESION DETAILS ARE UNKNOWN. WHILE ADVANCING THE 3.0X15MM EMERGE BALLOON CATHETER INSIDE THE PATIENT, THE CATHETER "SNAPPED." THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMERGE¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493919315300 15425725

    Patients

    Seq Age Sex Outcome Treatment
    1