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

Model Number FGS-0313

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Code Available (3191)

Event Date 01/30/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, when they fired during the procedure, the capsule failed to attach on the esophageal wall of the patient, it was removed by the use of the deliver catheter.The patient suffered a tear on the esophageal wall, and there was no user harm.A repeat procedure was done on the same day using another capsule.The customer noted the patient was not under anesthesia.The delivery system and capsule will be returned for investigation.

Manufacturer Narrative

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

Event Description

According to the reporter, when they fired during the procedure, the capsule failed to attach on the esophageal wall of the patient, it was removed by the use of the deliver catheter.The physician noticed blood on esophageal wall and mentioned that there was a mild tear, and no intervention was needed to treat the tear.A repeat procedure was done on the same day using another capsule.The customer noted the patient was not under anesthesia.The delivery system and capsule will be returned for investigation.

Manufacturer Narrative

Additional information: evaluation summary: this report is based on information provided by medtronic investigation personnel and bravo device arriving in bio lab.Bravo device was received for evaluation.The returned sample met specification as received by medtronic.The visual inspection found no notable conditions.The customer reported when they fired during the procedure, the capsule failed to attach on the esophageal wall of the patient, it was removed by the use of the deliver catheter.The investigation found the device to function normally and within specifications.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, when they fired during the procedure, the capsule failed to attach on the esophageal wall of the patient, and the capsule was removed by the use of the deliver catheter.The physician noticed blood on esophageal wall and mentioned that there was a mild tear, and no intervention was needed to treat the tear.No repeat procedure was done on a different day as another capsule was used to proceed with the procedure.The customer noted the patient was not under anesthesia.

• 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 ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 8457544
• MDR Text Key: 140121770
• Report Number: 9710107-2019-00124
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101361695
• UDI-Public: 07290101361695
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K102543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2019
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 07290101361688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2019
• Initial Date FDA Received: 03/27/2019
• Supplement Dates Manufacturer Received: 04/02/2019; 05/22/2019
• Supplement Dates FDA Received: 04/18/2019; 06/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2018
• 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