BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY BALLOON DILATATION CATHETER

    MDR report key: 2062896 · Received April 19, 2011

    Report

    Report Number
    2134265-2011-01515
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K993305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: AN EXAMINATION OF THE RETURNED DEVICE REVEALED A KINK 60MM PROXIMAL TO THE TIP OF THE DEVICE. THE BALLOON WAS NOT FOLDED OR WRAPPED AROUND THE SHAFT OF THE DEVICE. THERE WERE TRACES OF DRIED CONTRAST MEDIA VISIBLE INSIDE THE BALLOON. A SEVERE KINK WAS NOTED 40MM PROXIMAL TO THE TIP OF THE DEVICE (INSIDE THE BALLOON ON THE TIP). THE DEVICE WAS ATTACHED TO AN INFLATION UNIT IN AN ATTEMPT TO INFLATE THE BALLOON TO ITS RATED BURST PRESSURE, HOWEVER, THIS WAS NOT POSSIBLE DUE TO THE BUILD OF THE DRIED CONTRAST MEDIA PRESENT INSIDE THE BALLOON. THE DEVICE WAS IMMERSED IN WARM WATER TO DISSOLVE THE BUILD UP OF DRIED CONTRAST MEDIA. A SECOND ATTEMPT WAS MADE TO INFLATE THE BALLOON TO ITS RATED BURST PRESSURE, HOWEVER, THIS ATTEMPT WAS UNSUCCESSFUL. THE DEVICE WAS SOAKED IN WARM WATER FOR A LONGER PERIOD AND A THIRD ATTEMPT WAS MADE TO INFLATE THE BALLOON WHEN A LEAK WAS NOTED AT THE PROXIMAL BOND AREA. VISUAL AND MICROSCOPIC EXAMINATION OF THE AREA NOTED THAT THE BALLOON SLEEVE HAD SEPARATED FROM THE PROXIMAL BOND TOUCH UP. THE SHAFT ALSO SHOWED EVIDENCE OF STRETCHING AT THE PROXIMAL BOND. THE DAMAGE NOTED TO THE SHAFT MAY BE CONSISTENT WITH THE SHAFT BEING PULLED ON IN ORDER TO REMOVE THE DEVICE FROM THE SHEATH. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. 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).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PHYSICIAN ENCOUNTERED DIFFICULTIES WHILE REMOVING THE SYNERGY BALLOON CATHETER FROM THE SHEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE BALLOON CATHETER REMOVAL DIFFICULTIES OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS LEFT BRACHIAL 'REGION'. AFTER THE PHYSICIAN INFLATED THE SYNERGY BALLOON CATHETER AND DECIDED TO REMOVE IT, BALLOON CATHETER REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE PHYSICIAN REMOVED THE SYNERGY BALLOON AND THE NON-BSC 5FR INTRODUCER SHEATH AS A UNIT TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PHYSICIAN ENCOUNTERED DIFFICULTIES WHILE REMOVING THE SYNERGY BALLOON CATHETER FROM THE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY M001192910 13962925

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: RADIOFOCUS| INTRODUCER SHEATH: MOSQUITO 5F| INFLATION DEVICE: JMS