BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRAVO

    MDR report key: 7519349 · Received May 16, 2018

    Report

    Report Number
    9710107-2018-00711
    Event Type
    Injury
    Date Received
    May 16, 2018
    Report Date
    May 16, 2018
    Manufacturer
    GIVEN IMAGING LTD., YOQNEAM
    Product Code
    FFT
    UDI-DI
    07290101361688
    PMA / PMN Number
    K102543
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCES 1 WENNER J, JOHNSSON F, JOHANSSON J, OBERG S. WIRELESS OESOPHAGEAL PH MONITORING: FEASIBILITY, SAFETY AND NORMAL VALUES IN HEALTHY SUBJECTS. SCAND J GASTROENTEROL 2005; 40: 768-774 [PMID: 16118912 DOI: 10.1080/00365520510023602] 2 DE HOYOS A, ESPARZA EA. TECHNICAL PROBLEMS PRODUCED BY THE BRAVO PH TEST IN NONEROSIVE REFLUX DISEASE PATIENTS. WORLD J GASTROENTEROL 2010; 16: 3183-3186 [PMID: 20593504 DOI: 10.3748/WJG.V16.I25.3183] 3 VON RENTELN D, KAYSER T, RIECKEN B, CACA K. AN UNUSUAL CASE OF BRAVO CAPSULE ASPIRATION. ENDOSCOPY 2008; 40 SUPPL 2: E174 [PMID: 18668461 DOI: 10.1055/S-2007-995804] 4 HO KK, JOYCE AM. COMPLICATIONS OF CAPSULE ENDOSCOPY. GASTROINTEST ENDOSC CLIN N AM 2007; 17: 169-178, VIII-IX [PMID: 17397783 DOI: 10.1016/J.GIEC.2006.11.001]. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE CAPSULE DID NOT ATTACH TO THE PATIENT'S ESOPHAGUS AND COULD NOT BE ENDOSCOPICALLY VISUALIZED AFTER DEPLOYMENT. AFTER MULTIPLE ATTEMPTS TO DETECT THE CAPSULE, IT WAS VISUALIZED IN THE LEFT PYRIFORM SINUS. DUE TO THE SIGNIFICANT RISK FOR PULMONARY DISLODGEMENT, ENT AND PULMONARY PHYSICIANS WERE IMMEDIATELY CONSULTED TO REVIEW OPTIONS FOR SAFE REMOVAL. THE ANESTHESIOLOGIST PERFORMED ENDOTRACHEAL INTUBATION AND THE ENT WAS ABLE TO SUCCESSFULLY REMOVE THE CAPSULE WITH FOREIGN BODY FORCEPS WITHOUT FURTHER COMPLICATION. IT IS SUSPECTED THAT THE CAPSULE WAS EITHER PULLED UP BY THE ENDOSCOPE DURING WITHDRAWAL, OR COUGHED UP BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360645 BRAVO ELECTRODE, PH, STOMACH FFT GIVEN IMAGING LTD., YOQNEAM FGS-0313 07290101361688

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention