MAUDE Adverse Event Report: MEDTRONIC / GIVEN IMAGING, INC. BRAVO; ELECTRODE, PH, STOMACH

Lot Number 56255F

Device Problems Positioning Failure (1158); Patient Device Interaction Problem (4001)

Patient Problems Aspiration/Inhalation (1725); Cough (4457)

Event Date 07/07/2022

Event Type  Injury  

Event Description

During attempted bravo capsule placement, capsule did not attach to esophagus.Chest xray taken and capsule found in back of oropharynx.Before capsule was able to be retrieved, patient inhaled it.Chest xray showed capsule in the left bronchi.Patient was intubated and bronchoscopy was performed to remove capsule.Pt coughed multiple times during intubation.Bronchoscopy did not find capsule.Chest xray showed capsule was back in the oropharynx.Glidescope was inserted and capsule was found and removed with forceps.Pt oxygen remained stable throughout this incident.Pt was sent to pacu and discharged home the same day.Fda safety report id# (b)(4).

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): MEDTRONIC / GIVEN IMAGING, INC.
• MDR Report Key: 15067140
• MDR Text Key: 296324834
• Report Number: MW5110982
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 56255F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BRAVO REFLUX CAPSULE
• Patient Outcome(s): Life Threatening; Required Intervention