BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8F BGC 95CM

    MDR report key: 2863294 · Received December 10, 2012

    Report

    Report Number
    0002954917-2012-00127
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 3, 2012
    Report Date
    November 13, 2012
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    DQY
    PMA / PMN Number
    K112404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. ANALYSIS OF THE DEVICE SHOWED A KINK ON THE SHAFT APPROXIMATELY 16CM FROM THE DISTAL TIP AND TWO WRINKLES ON THE BALLOON OUTER DIAMETER. DURING FUNCTIONAL TESTING, RESISTANCE WAS EXPERIENCED USING AIR INFLATION/DEFLATION METHOD AND WHEN THE BALLOON INFLATED IT FORMED A D SHAPE. INFLATION OF THE BALLOON WITH WATER REVEALED THAT THE INFLATION LUMEN WAS OCCLUDED. MICROSCOPE EXAMINATION OF THE BALLOON¿S WRINKLES REVEALED THAT ONE FOLD WAS LOCATED AT THE PROXIMAL INFLATION HOLE AND THE FOLD OBSTRUCTED THE INFLATION LUMEN. ADDITIONAL INFORMATION INDICATED THAT THE DEVICE WAS CONFIRMED TO BE IN GOOD CONDITION POST UNPACKING AND PREPARATION AND THAT THERE WERE NO ISSUES DURING INFLATION AND DEFLATION AT THE PREPARATION STAGE. BASED ON ALL THE INFORMATION AVAILABLE, IT IS PROBABLE THAT THE DEVICE FINDINGS OCCURRED DURING USE; LIMITING ITS PERFORMANCE WHICH RESULTED IN THE REPORTED ISSUE. THEREFORE A ROOT CAUSE OF OPERATIONAL CONTEXT HAS BEEN ASSIGNED TO THIS INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MECHANICAL THROMBECTOMY TO TREAT AN ISCHEMIC STROKE, THE BALLOON GUIDE CATHETER (BGC) INFLATED IN A "D" SHAPE. THE BGC DEFLATION WAS LENGTHY AND IT DID NOT COMPLETELY DEFLATE. THE BGC WAS ABLE TO PASS THROUGH THE SHEATH AND IT WAS SAFELY REMOVED FROM THE PATIENT'S BODY WITHOUT ANY CLINICAL CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MECHANICAL THROMBECTOMY TO TREAT AN ISCHEMIC STROKE, THE BALLOON GUIDE CATHETER (BGC) INFLATED IN A "D" SHAPE. THE BGC DEFLATION WAS LENGTHY AND IT DID NOT COMPLETELY DEFLATE. THE BGC WAS ABLE TO PASS THROUGH THE SHEATH AND IT WAS SAFELY REMOVED FROM THE PATIENT'S BODY WITHOUT ANY CLINICAL CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8F BGC 95CM CATHETER, PERCUTANEOUS DQY CONCENTRIC MEDICAL 35443

    Patients

    Seq Age Sex Outcome Treatment
    1