BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX MONORAIL

    MDR report key: 1832636 · Received September 13, 2010

    Report

    Report Number
    2134265-2010-04083
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    July 26, 2010
    Report Date
    August 26, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE HYPOTUBE WAS KINKED AT VARIOUS LOCATIONS ALONG ITS LENGTH. ONE SEVERE RIGHT ANGLED KINK WAS PRESENT 37CM DISTAL TO THE STRAIN RELIEF. THE DISTAL SUB ASSEMBLY EXTRUSION WAS KINKED AT VARIOUS LOCATIONS ALONG ITS LENGTH. A BUILD UP OF SOLIDIFIED BLOOD WAS PRESENT INSIDE THE MIDSHAFT. THE DEVICE WAS ATTACHED TO AN INFLATION UNIT AND DURING ATTEMPTS TO INFLATE THE BALLOON A LEAK WAS OBSERVED. THE LEAK WAS LOCATED OVER THE PROXIMAL EDGE OF THE DISTAL MARKERBAND. A DETAILED MICROSCOPIC EXAMINATION OF THE LEAK SITE IDENTIFIED A 0.5MM LONGITUDINAL TEAR IN THE BALLOON. AN EXAMINATION OF THE BALLOON MATERIAL AND PROXIMAL MARKERBAND DID NOT IDENTIFY ANY ISSUES WHICH COULD POTENTIALLY HAVE CONTRIBUTED TO THE TEAR. 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 AND/OR PROCEDURAL FACTORS. (B)(4)

    Description of Event or Problem · 1

    REPORTABLE BASED ON THE PRODUCT ANALYSIS COMPLETED ON (B)(6) 2010. IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, THE BALLOON FAILED TO INFLATE. THE STENOTIC, ECCENTRIC, DE NOVO LESION WAS LOCATED IN THE MILDLY CALCIFIED LEFT CIRCUMFLEX ARTERY. THE PHYSICIAN ADVANCED THE 2.5X15MM APEX BALLOON TO THE LESION BUT WAS UNABLE TO INFLATE THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A NON-BSC BALLOON AND THE DEPLOYMENT OF A 2.5X28MM PROMUS ELEMENT STENT. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, THE RETURNED PRODUCT ANALYSIS REVEALED THAT THE BALLOON WAS TORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MONORAIL CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H7493895915250 0013309292

    Patients

    Seq Age Sex Outcome Treatment
    1 TERUMO NS RUNTHROUGH GUIDE WIRE