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

Model Number FGS-0313

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Blood Loss (2597)

Event Date 02/15/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, the capsule attached, but it did not detach from the delivery system.The capsule had to be completely removed from the mucosa of the esophagus.The patient had a minute bleeding on the site, no intervention was required, and another capsule was used to proceed with the procedure.There was nothing unusual about the patient or the procedure and an endoscopy had been performed prior to the procedure and showed the esophagus to be normal.No lubrication was used to facilitate placement of the capsule and 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 the sample that arrived.One bravo capsule and one bravo delivery device were received for evaluation.A review of the product expiration date discovered this product was used before the expiration date.The returned sample met specification as received by medtronic.The visual inspection found no notable conditions.The customer reported bravo fail to attach to patient's esophagus.The investigation of the returned equipment did not identify anything that would have caused or contributed to the reported event.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, the first capsule failed to calibrate.A second capsule was used, it attached but it did not detach from the delivery system.The capsule had to be completely removed from the mucosa of the esophagus.The patient had a minute bleeding on the site, no intervention was required to stop the bleeding, and a third capsule was used to proceed with the procedure.There was nothing unusual about the patient or the procedure and an endoscopy had been performed prior to the procedure and showed the esophagus to be normal.No lubrication was used to facilitate placement of the capsule and the delivery system.

• 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: 8438230
• MDR Text Key: 139414931
• Report Number: 9710107-2019-00114
• 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: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2019
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 42309Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Date Manufacturer Received: 04/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2018
• 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 Age: 59 YR