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

Model Number FGS-0313

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Radiation Exposure, Unintended (3164)

Event Date 02/28/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, immediately after the capsule was placed, the patient felt pain in her chest radiating towards her back and experienced difficulty of breathing after the capsule placement recovery period.The physician advised the patient to take pain medication and was sent home.The patient went to a hospital's emergency room later in the evening for pain with the scale of 7 out of 10, requested the capsule to be removed, and was admitted for pain management.The capsule was not removed as advised by the physician to avoid tearing of the esophageal wall.Chest x-ray was performed and showed that the capsule was still in place, but the emergency physician also refused to remove the capsule.Five days after the capsule was placed, the patient came in for follow-up and had another chest x-ray was performed, and the capsule was no longer attached.The patient was no longer in severe pain.

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692 ; IL 20692
• Manufacturer (Section G): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692 ; IL 20692
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 9883399
• MDR Text Key: 185481447
• Report Number: 9710107-2020-00150
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101361688
• UDI-Public: 07290101361688
• 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: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2020
• 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
• Patient Age: 20 YR