MAUDE Adverse Event Report: GIVEN IMAGING INC. BRAVO PH CAPSULE WITH DELIVERY SYSTEM-FGS 0313; ELECTRODE, PH, STOMACH

Lot Number 50495Q

Device Problems Difficult to Remove (1528); Failure to Align (2522)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/08/2020

Event Type  malfunction  

Event Description

Pt had e.G.D./bravo capsule.Bravo cap deployed; did not stick to target area in esophagus.Capsule visualized in pt's throat; unable to retrieve.Pt will have bronch.As per dr.To retrieve capsule.Also spoke to pt, pt's family [via phone].Fda safety report id# (b)(4).

• Brand Name: BRAVO PH CAPSULE WITH DELIVERY SYSTEM-FGS 0313
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING INC.
• MDR Report Key: 10697935
• MDR Text Key: 215021342
• Report Number: MW5097303
• Device Sequence Number: 1
• Product Code: FFT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 50495Q
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR