MAUDE Adverse Event Report: GIVEN IMAGING, INC. BRAVO CF CAPSULE DELIVERY DEV,1-PK; ELECTRODE, PH, STOMACH

Model Number FGS-0636

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Airway Obstruction (1699); Cough (4457)

Event Date 09/12/2022

Event Type  malfunction  

Event Description

During the patient's procedure, the md attempted to place a ph bravo probe at 34cm.Suction was applied to the probe's suction port and the md proceeded to apply the ph probe.The md re-entered the esophagus with the scope and as the applicator was being removed, he saw that the probe was still attached to the device.The ph probe became unattached and was in the patient's upper oral airway.Md attempted to remove the probe, but the patient started coughing and he was unable to visualize the probe.The md entered the mouth and looked for the probe and was unable to visualize it believing the probe was aspirated by the patient, pulmonary staff was called, and bronchoscopy was done.The airways were clear without signs of probe or trauma.Anesthesia staff used intubation equipment to visualize the oral airway and the probe was seen in the upper airway.Mcgill forceps were used to retrieve the probe.

• Brand Name: BRAVO CF CAPSULE DELIVERY DEV,1-PK
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING, INC.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 15759124
• MDR Text Key: 303326668
• Report Number: 15759124
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101369714
• UDI-Public: 07290101369714
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/27/2022,10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FGS-0636
• Device Lot Number: 56756F
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/27/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/09/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12410 DA
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Race: White