MAUDE Adverse Event Report: GIVEN IMAGING BRAVO REFLUX TESTING SYSTEM; BRAVO CAPSULE

Model Number 66F2

Device Problem Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/13/2016

Event Type  malfunction  

Event Description

Gi physician placed bravo capsule.The insertion catheter was placed in the mouth into the esophagus.The physician did not notice anything different from previous uses of the device.When viewing placement of the capsule by egd, the capsule was not found in the esophagus.X-ray showed that the capsule was located in the pt's nasal pharynx.The pt was taken to the operating room where the capsule was removed by endoscopy.

• Brand Name: BRAVO REFLUX TESTING SYSTEM
• Type of Device: BRAVO CAPSULE
• Manufacturer (Section D): GIVEN IMAGING; minneapolis MN 55432
• MDR Report Key: 6046767
• MDR Text Key: 58253389
• Report Number: MW5065540
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 66F2
• Device Lot Number: 31764Q
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 12 YR
• Patient Weight: 52