MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM BRAVO; ELECTRODE, PH, STOMACH

Model Number FGS-0635

Device Problem Entrapment of Device (1212)

Patient Problems Chest Pain (1776); Foreign Body In Patient (2687); Unintended Radiation Exposure (4565)

Event Date 02/24/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the capsule failed to attach during the first attempt and the device came apart on its own during the procedure while trying to deploy, with the plunger and spring falling out.The first capsule was retrieved still attached to the delivery system.A second attempt was performed but the physician had a hard time turning the plunger, but it did deploy.Five days after the procedure, an x-ray was performed on the patient as the capsule was still inside the patient's body.The patient is now having chest pain.The capsule was taken out the patient.

Manufacturer Narrative

Corrected information: mfr site.Evaluation summary: medtronic conducted an investigation based upon all information received.The capsule and delivery system were returned for evaluation.Visual inspection noted the plunger had been rotated more than one-eigth of a turn.It was reported that the capsule remained in the patient longer than expected.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: pressing down on the plunger too slowly may result in the capsule not properly attaching to the patient¿s esophagus or not detaching from the delivery device.Do not rotate the plunger while depressing it.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the capsule failed to attach during the 1st attempt and the device came apart on its own during the procedure while trying to deploy, with the plunger and spring falling out.The first capsule was retrieved still attached to the delivery system.A second attempt was performed on the same day but the physician had a hard time turning the plunger, but it did deploy.The patient was under iv sedation.Five days after the procedure an x-ray was performed on the patient as the capsule is still inside the patient's body.The patient is now having chest pain.The capsule was taken out the patient.

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692 ; IS 20692
• Manufacturer (Section G): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692 ; IS 20692
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 11568453
• MDR Text Key: 242211782
• Report Number: 9710107-2021-00158
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101369707
• UDI-Public: 07290101369707
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2022
• Device Model Number: FGS-0635
• Device Catalogue Number: FGS-0635
• Device Lot Number: 51738F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 03/25/2021
• Supplement Dates Manufacturer Received: 05/31/2021
• Supplement Dates FDA Received: 06/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention