BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 6844402 · Received September 6, 2017

    Report

    Report Number
    9710107-2017-05469
    Event Type
    Malfunction
    Date Received
    September 6, 2017
    Date of Event
    August 28, 2017
    Report Date
    August 28, 2017
    Manufacturer
    GIVEN IMAGING LTD., YOQNEAM
    Product Code
    FFT
    PMA / PMN Number
    K102543
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: IT WAS REPORTED THAT ONE BRAVO PH CAPSULE FAILED TO DETACH FROM THE DELIVERY DEVICE ONTO THE PATIENT ESOPHAGUS. ONE BRAVO PH CAPSULE DELIVERY DEVICE WAS RECEIVED FOR INVESTIGATION. THE CAPSULE WAS NOT ATTACHED TO THE DELIVERY DEVICE. THE CAPSULE WAS NOT RECEIVED FOR INVESTIGATION. VISUAL INSPECTION DID NOT REVEAL ANY DAMAGE EXCEPT A BENT GUIDE WIRE, AND APPEARS TO HAVE FUNCTIONED WITHIN SPECIFICATION. FUNCTIONAL TESTING COULD NOT BE PERFORMED BECAUSE THIS IS A SINGLE USE DEVICE AND ONCE THE CAPSULE IS DELIVERED IT CANNOT BE FUNCTIONALLY TESTED. INVESTIGATION CONCLUSION FOR THE FAILURE TO ATTACH COULD NOT BE RELIABLY DETERMINED. ADDITIONALLY, A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND INDICATES THAT THE PRODUCT WAS RELEASED MEETING FINISHED PRODUCT SPECIFICATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE BRAVO CAPSULE FAILED TO DETACH FROM DELIVERY DEVICE, NO HARM WAS CAUSED TO THE PATIENT AND A REPEAT P PROCEDURE WAS NOT PERFORMED. THE USER REPORTED A SNARE WAS USED TO RETRIEVE THE CAPSULE AND THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR THE PROCEDURE WHICH LED TO THE INCIDENT. PRIOR TO THE PROCEDURE AN ENDOSCOPY WAS PERFORMED AND THE ESOPHAGUS APPEARED TO BE N NORMAL. THE PHYSICIAN HAS BEEN PERFORMING THE BRAVO PROCEDURE FOR ABOUT 5 YEARS, AND WAS TRAINED BY A GIVEN REPRESENTATIVE. IT IS UNKNOWN WHAT THE VACUUM PRESSURE WAS BEFORE THE PROCEDURE AS NO PRE-PROCEDURE WAS PERFORMED, BUT THE PRESSURE DURING PLACEMENT WAS 686, AND NO LUBRICANT WAS USED TO FACILITATE CAPSULE PLACEMENT. THE DELIVERY SYSTEM AND THE CAPSULE WILL BE RETURNED TO GIVEN, THE PHYSICIAN BELIEVES THE MALFUNCTION WAS DUE TO THE MEDELA PUMP NOT SUCTIONING CORRECTLY AT THE TIME OF CAPSULE PLACEMENT. CUSTOMER TESTED SUCTION AFTER FTD AND ALTHOUGH THE PRESSURE READING WAS 686, THERE WAS NO SUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625585 BRAVO ELECTRODE, PH, STOMACH FFT GIVEN IMAGING LTD., YOQNEAM FGS-0313 35301Q

    Patients

    Seq Age Sex Outcome Treatment
    1