BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 4021336 · Received July 8, 2014

    Report

    Report Number
    9710107-2014-00140
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    GIVEN IMAGING LTD.
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ONE DELIVERY SYSTEM AND CAPSULE WERE RETURNED TO MEDTRONIC FOR EVALUATION. THE DELIVERY SYSTEM WAS INVESTIGATED VISUALLY FOR EXTERNAL DAMAGE. THE TROCAR NEEDLE WAS ADVANCED. THE DELIVERY SYSTEM WAS BENT AT THE GUIDE WIRE, BUT THE PLUNGER WAS NOT BROKEN. THE PLUNGER WAS NOT PUSHED TO THE END. THE EMERGENCY RELEASE ON THE DELIVERY SYSTEM WAS NOT IMPLEMENTED. THE CAPSULE ELECTRODES WERE VISUALLY ACCEPTABLE. THE WIRE THAT HOLDS THE CAPSULE WAS COMPLETELY OFF AND THE FOAM GASKET WAS IN GOOD CONDITION. THE DELIVERY SYSTEM DID NOT HAVE ANY VISIBLE DAMAGE. AS THE PRODUCT WAS RECEIVED, THE BENT GUIDEWIRE IS INDICATIVE OF MISHANDLING. THERE WAS NO REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE IN THIS CASE. THE INFORMATION WAS UPDATED IN THIS SUPPLEMENTAL.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ON A BRAVO PH CAPSULE THAT FAILED TO ATTACH. THE PATIENT WAS NOT INJURED FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPEAT PROCEDURE WAS NECESSARY DUE TO THE ALLEGED DEVICE MALFUNCTION. THE PHYSICIAN USED THE EMERGENCY RELEASE WHEN THEY DIDN'T SEE THE CABLE TO RELEASE THE CAPSULE. AS SUCH, THEY FORCED THE CAPSULE FROM THE PATIENT'S ESOPHAGUS. AN ENDOSCOPY WAS PERFORMED PRIOR TO THE PROCEDURE AND THE PATIENT APPEARED TO HAVE ESOPHAGITIS. THE DEVICE OPERATOR HAS BEEN PERFORMING THIS PROCEDURE FOR OVER SIX YEARS. NO KNOWN ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398486 BRAVO BRAVO PH CAPSULE FFT GIVEN IMAGING LTD. FGS-0313 23371Q

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention