MAUDE Adverse Event Report: GIVEN IMAGING INC. BRAVO CF CAPSULE; ELECTRODE, PH, STOMACH

Model Number FGS-0636

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 10/20/2021

Event Type  malfunction  

Event Description

Surgeon "felt resistance" when attempting to remove the catheter once capsule was deployed.Device disassembled by breaking the handle which releases the capsule and permitted removal of catheter.Warning label on product for such occurrence.Endoscopically confirmed the capsule was not attached.Retrieved with a net and additional bravo cf capsule with same lot number placed.Again, resistance was felt and once handle broken the catheter was removed.Endoscopically confirmed capsule placement.

Event Description

Surgeon "felt resistance" when attempting to remove the catheter once capsule was deployed.Device disassembled by breaking the handle which releases the capsule and permitted removal of catheter.Warning label on product for such occurrence.Endoscopically confirmed the capsule was not attached.Retrieved with a net and additional bravo cf capsule with same lot number placed.Again, resistance was felt and once handle broken the catheter was removed.Endoscopically confirmed capsule placement.

• Brand Name: BRAVO CF CAPSULE
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING INC.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 13548514
• MDR Text Key: 285740645
• Report Number: 13548514
• Device Sequence Number: 1
• Product Code: FFT
• 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,Followup
• Report Date: 02/03/2022,11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FGS-0636
• Device Catalogue Number: FGS-0636
• Device Lot Number: 54185F
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/03/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/17/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24820 DA
• Patient Sex: Female
• Patient Weight: 94 KG
• Patient Race: Black Or African American