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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GIVEN IMAGING INC. BRAVO PH CAPSULE; ELECTRODE, PH, STOMACH
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GIVEN IMAGING INC. BRAVO PH CAPSULE; ELECTRODE, PH, STOMACH Back to Search Results
Lot Number 44426Q
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/03/2019
Event Type  Injury  
Event Description
A (b)(6) pt presented as an outpatient for a repeat egd with bravo capsule placement due to capsule migrating after previous placement.Egd completed.Bravo capsule was deployed but did not attach to the pt's esophagus.Pt then took a deep breath and appeared to aspirate the capsule.Capsule could not be located in the pt's esophagus.A pulmonologist was called to perform an emergent bronchoscopy.The airway was found to be clear.A repeat egd was performed and the capsule was found and retrieved.Unsuccessful in placing the capsule but being treated for gastroesophageal reflux.Pt discharged home same day with plans to f/u with gastroenterology as an outpatient.Fda safety report id# (b)(4).
 
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Brand Name
BRAVO PH CAPSULE
Type of Device
ELECTRODE, PH, STOMACH
Manufacturer (Section D)
GIVEN IMAGING INC.
MDR Report Key8523000
MDR Text Key142359944
Report NumberMW5085928
Device Sequence Number1
Product Code FFT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 04/12/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received04/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Lot Number44426Q
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/03/2019
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age59 YR
Patient Weight81
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