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 Problems Hernia (2240); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, they had a capsule which failed to attach.There was no harm to the patient, but an intervention was required wherein they had to stabilize the airway, then remove the capsule using forceps, and a repeat procedure was performed.The patient had a barrett¿s esophagus and hiatal hernia.An endoscopy had been performed prior to the procedure and showed the esophagus to be normal.Lubrication was used to facilitate placement of the capsule and the delivery system and capsule will be returned for investigation.The implant was removed with anesthesia assistance without harm to the patient.

Manufacturer Narrative

Additional information:patient code - (b)(6) (stabilize airway using forceps) 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.

• 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: 8370838
• MDR Text Key: 137166035
• Report Number: 9710107-2019-00067
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2019
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 43589Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2018
• 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): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 90