BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENT - BALLOON CATHETER

    MDR report key: 3820304 · Received May 20, 2014

    Report

    Report Number
    1226348-2014-00112
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 25, 2014
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    MJN
    PMA / PMN Number
    K080861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON 6/25/2014: THE PROCEDURE DATE WAS (B)(6) 2014. THE INTENDED PROCEDURE WAS BALLOON BUTTRESSED COIL OCCLUSION OF A SUPRACLINOID RIGHT INTERIOR CAROTID ARTERY. COMPLAINT CONCLUSION: DURING PREP FOR A BALLOON BUTTRESSED COIL OCCLUSION OF A SUBPACLINOID RIGHT INTERNAL CAROTID ARTERY ANEURYSM, A 4MM X 10CM ASCENT BALLOON CATHETER (BRC00041000/C14186), THE BALLOON WAS NOTED TO BE PERFORATED. THERE HAD BEEN NO DIFFICULTY IN REMOVING THE DEVICE FROM THE PACKAGING AND THERE WAS NO DAMAGE PRIOR TO PREP. THE BALLOON WAS PREPPED WITH 100% CONTRAST AND THE PHYSICIAN HAD DIFFICULTY PURGING AIR OUT, REQUIRING TOO MUCH PRESSURE ON THE BALLOON. THE SYRINGE SIZE USED FOR PREPPING THE BALLOON IS UNKNOWN. THE DEVICE WAS NOT USED IN THE PATIENT, AND IT WAS UNKNOWN HOW THE PROCEDURE WAS FINALLY COMPLETED. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE REGARDING THE INTENDED PROCEDURE OR PATIENT DEMOGRAPHICS. BECAUSE OF THE CONDITIONS OF THE RETURNED UNIT, (DRY CONTRAST MEDIA IN THE BALLOON AREA) NO FUNCTIONAL TESTING COULD BE EXECUTED (INFLATION TEST) TO DETERMINE WHETHER THE BALLOON IS PERFORATED. THE VISUAL INSPECTION WAS LIMITED DUE TO DRY CONTRAST AROUND THE BALLOON, ON THE REST OF THE DEVICE, NO OTHER DEFECT WAS OBSERVED. IN CONCLUSION, IT COULDN¿T BE DETERMINED WHETHER THE BALLOON IS PERFORATED AND/OR OTHERWISE FUNCTIONING AS EXPECTED. THE DHR REVIEW FOUND NO ANOMALIES AND ALL PERSONNEL WORKING ON THE PROCESS WERE CERTIFIED AND TRAINED. THE BALLOON PERFORATION COULD NOT BE CONFIRMED BECAUSE OF THE CONDITION OF THE RETURNED PRODUCT. A INFLATION TEST COULD NOT BE PERFORMED DUE TO DRY CONTRAST MEDIA. BASED ON THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OR FACTORS THAT MAY HAVE CONTRIBUTED TO THE PERFORATION. INSPECTIONS ARE IN PLACE TO PREVENT THIS TYPE OF DAMAGE FROM LEAVING THE MANUFACTURING FACILITY AND THE MANUFACTURING DOCUMENTATION FOUND NO ANOMALIES. NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    LOT# C14186. (B)(6). THE EVENT OCCURRED IN 4/2014, BUT THE EXACT DATE WAS NOT PROVIDED. THE DEVICE HAS BEEN RETURNED FOR ANALYSIS; HOWEVER, THE ANALYSIS HAS NOT YET BEEN COMPLETED. A REVIEW OF LOT C14186 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING PREP OF A 4MM X 10CM ASCENT BALLOON CATHETER (BRC00041000/C14186), THE BALLOON WAS NOTED TO BE PERFORATED. THERE HAD BEEN NO DIFFICULTY IN REMOVING THE DEVICE FROM THE PACKAGING AND THERE WAS NO DAMAGE PRIOR TO PREP. THE BALLOON WAS PREPPED WITH 100% CONTRAST AND THE PHYSICIAN HAD DIFFICULTY PURGING AIR OUT, REQUIRING TOO MUCH PRESSURE ON THE BALLOON. THE SYRINGE SIZE USED FOR PREPPING THE BALLOON IS UNKNOWN. THE DEVICE WAS NOT USED IN THE PATIENT, AND IT WAS UNKNOWN HOW THE PROCEDURE WAS FINALLY COMPLETED. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE REGARDING THE INTENDED PROCEDURE OR PATIENT DEMOGRAPHICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299527 ASCENT - BALLOON CATHETER CES BALLOON CATHETER MJN MICRUS ENDOVASCULAR, LLC NA SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1