MAUDE Adverse Event Report: GIVEN IMAGING BRAVO REFLUX DELIVERY DEVICE

Lot Number 44104F

Device Problem Malposition of Device (2616)

Patient Problem Respiratory Distress (2045)

Event Date 03/13/2019

Event Type  Injury  

Event Description

The bravo capsule with delivery system was introduced through the mouth and advanced into the esophagus.The capsule was positioned 30 cm from the incisors which was 6 cm proximal to the eg junction.The bravo p capsule was then deployed and the delivery system was withdrawn.Endoscopy was utilized for probe placement.The placement failed and upon inspection was found to be in the oropharyngeal area.The bravo capsule was removed using a roth net.The pt's oxygen saturation went down to 86%, so another attempt at placement was not done.The pt was able to be discharged after the procedure.I was made aware of this event at the time of occurrence.The gi staff wanted to review what happened with the vendor.After this was reviewed, the chair for gi recommended this be reported.I was made aware of the findings from the vendor's visit on 05/13/2019.Diagnosis for use: acid reflux.

• Brand Name: BRAVO REFLUX DELIVERY DEVICE
• Type of Device: BRAVO REFLUX DELIVERY DEVICE
• Manufacturer (Section D): GIVEN IMAGING; mansfield MA 02048
• MDR Report Key: 8632392
• MDR Text Key: 145912996
• Report Number: 8632392
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 44104F
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/13/2019
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Weight: 108