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

Model Number FGS-0313

Device Problem Entrapment of Device (1212)

Patient Problem Chest Pain (1776)

Event Date 03/22/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, five days after the placement of the capsule, the patient went to the emergency room due to severe chest pain and odynophagia and the patient was admitted.Computerized tomogram was performed and confirmed that the capsule was still attached.There was no abdominal pain.The capsule was removed with gastroesophageal endoscopy.Erosive esophagitis was noted during the procedure of extracting the retained capsule.The patient had a history of gastroesophageal reflux disease, depression, anxiety, chronic headaches, and esophagitis.The patient had an ongoing medication of esomeprazole 20 mg and aleve.

Manufacturer Narrative

Evaluation summary: this report is based on information provided by the complaint tracking system.No product was received.Since no sample was returned for investigation it is impossible to determine if product meet specs or not.The customer reported that five days after the placement of the capsule, the patient went to the emergency room due to severe chest pain and odynophagia and the patient was admitted.Without the sample a detailed investigation could not be performed.The file will be closed as unconfirmed at this time.If additional information is obtained, or the sample is returned, we will re-open this investigation.Evaluation was not perfumed since the product sample did not arrive for investigation.The failure cause was not found since the product sample did not arrive for investigation.If information is provided in the future, a supplemental report will be issued.

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• Manufacturer (Section G): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• Manufacturer Contact: amy beeman ; 5920 longbow drive; boulder, CO 80301 ; 7632104064
• MDR Report Key: 8556308
• MDR Text Key: 143275403
• Report Number: 9710107-2019-00185
• 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: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/30/2019

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: 08/08/2019
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 41928Q
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/09/2019
• Initial Date FDA Received: 04/26/2019
• Supplement Dates Manufacturer Received: 08/13/2019
• Supplement Dates FDA Received: 08/30/2019
• Date Device Manufactured: 08/08/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 27 YR
• Patient Weight: 68