MAUDE Adverse Event Report: COVIDIEN LP BRAVO; ELECTRODE, PH, STOMACH

Model Number FGS-0636

Device Problems Malposition of Device (2616); Activation Failure (3270)

Patient Problem Insufficient Information (4580)

Event Date 10/05/2021

Event Type  malfunction  

Event Description

Bravo device failed to deploy properly to esophageal wall.It was found endoscopically near patient¿s epiglottis/vocal cords while pulling scope out.The mouth guard was removed from patient¿s mouth and finger sweep method used to remove device from patient¿s mouth.A new device deployed successfully on second attempt.

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12672144
• MDR Text Key: 277672901
• Report Number: 12672144
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101369714
• UDI-Public: (01)07290101369714
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FGS-0636
• Device Lot Number: 54189F
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/11/2021
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20075 DA