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

Model Number FGS-0636

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

Patient Problems Dyspnea (1816); Reaction (2414); Choking (2464)

Event Date 05/01/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, they performed a study and suspect that the patient may have had some reaction to the deployment device.Once the capsule was placed and the patient was in recovery, the patient reported having shortness of breath and she started choking.They provided breathing treatment using racemic epipen and decadron iv, and it subsided after approximately 4 hours and the patient was able to eat and sit up, so they felt comfortable discharging the patient.The rest of the study continued without any adverse event.

Manufacturer Narrative

Evaluation summary: this report is based on information provided by the complaint tracking system.The product sample was not returned to the medtronic laboratory; however, a graph of the study was provided by the customer for analysis.The returned sample meet specification as received by medtronic.The customer reported they performed a study and suspect that the patient may have had some reaction to the deployment device.The reported condition was confirmed.The investigation found, base on the event description the patient experience an allergic reaction probably from the epoxy resin found in the bravo capsule.After the procedure, the patient remembered and reported on a known allergy according to a skin test she had done 20 years ago.The report showed positive allergy response to: ethylene diamine dehydrate, epoxy resin and potassium dichromate.The engineers in qa have reviewed the materials and suggest that there may be a relationship the epoxy resin allergy reported by the patient and the epoek 301 adhesive used for the capsule.The device functioned normally.The procedure proceeded as usual, after the allergic reaction was treated and completely resolved.The investigation identified the cause of the reported event to be physiological problem.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, they performed a study and suspect that the patient may have had some reaction to the deployment device.Once the capsule was placed and the patient was in recovery, the patient reported having shortness of breath and she started choking.They provided breathing treatment using racemic epipen and decadron iv, and it subsided after approximately 4 hours and the patient was able to eat and sit up, so they felt comfortable discharging the patient.The rest of the study continued without any adverse event.The patient denied any allergies to nickel or any other metal.However, 20 years ago, the patient had a allergy skin testing wherein there was a positive allergy response to ethylene diamine dehydrate, epoxy resin, and potassium dichromate.

• Brand Name: BRAVO CAPSULE
• 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: 8645658
• MDR Text Key: 146225211
• Report Number: 9710107-2019-00230
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101369714
• UDI-Public: 07290101369714
• 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: consumer,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2020
• Device Model Number: FGS-0636
• Device Catalogue Number: FGS-0636
• Device Lot Number: 44778F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2019
• 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: 85 YR
• Patient Weight: 53