BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG?

    MDR report key: 3030558 · Received April 2, 2013

    Report

    Report Number
    2134265-2013-01909
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K103751
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS AND VISUAL EXAMINATION OF THE BALLOON MATERIAL IDENTIFIED A LONGITUDINAL TEAR IN THE BALLOON. THE TEAR WAS LOCATED AT 1MM DISTAL TO THE DISTAL EDGE OF THE DISTAL MARKERBAND AND IT EXTENDED PROXIMALLY ALONG THE BALLOON FOR A TOTAL LENGTH OF 14MM. A MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL AND MARKERBANDS 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/PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED WITH A 10FR NON BSC SHEATH VIA THE RIGHT INTERNAL JUGULAR ARTERY. THE INTENDED LOCATION FOR TREATMENT WAS THE INTRAHEPATIC PARYENCHIMAL LIVER TRACT. THIS 3.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS SELECTED FOR PRE-DILATATION AND WAS ADVANCED TO THE TARGET LESION WITHOUT RESISTANCE. DURING THE FIRST INFLATION OF 6ATMS A BALLOON RUPTURE OCCURRED. THE MUSTANG BALLOON CATHETER WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.0 X 20, 75CM MUSTANG BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED WITH A 10FR NON BSC SHEATH VIA THE RIGHT INTERNAL JUGULAR ARTERY. THE INTENDED LOCATION FOR TREATMENT WAS THE INTRAHEPATIC PARENCHYMAL LIVER TRACT. THIS 3.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS SELECTED FOR PRE-DILATATION AND WAS ADVANCED TO THE TARGET LESION WITHOUT RESISTANCE. DURING THE FIRST INFLATION OF 6ATMS A BALLOON RUPTURE OCCURRED. THE MUSTANG BALLOON CATHETER WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.0 X 20, 75CM MUSTANG BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134172 MUSTANG? CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939171030270 0015368695

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR GUIDE WIRE: 035 AMPLATZ| INTRODUCER SHEATH: 10F COOK