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

Model Number FGS-0313

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Itching Sensation (1943); Swelling (2091); Tingling (2171)

Event Date 12/18/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, customer called to report a patient with allergic reaction to capsule after placement.Patient called customer and informed swelling in eyes, face purplish red, itching (red all over), lips tingling and shortness of breath.Customer requested medical advice and would like to know if the capsule has any sulfur.The capsule test only lasted for 24 hours because patient needed to come back to the hospital to have the capsule taken out.

Manufacturer Narrative

Additional information:(mfr.Name, name, street, mfr.City, region, postal code, email), (phone #, fax #),evaluation summary: this report is based on information provided by medtronic investigation personnel.The capsule was received for investigation to yokneam team.The returned sample met specification as received by medtronic.The visual inspection found no notable conditions.The customer reported the patient had an allergic reaction while having bravo procedure, symptoms including swelling in eyes, itching' shortness of breath and that the allergy symptoms stopped once the capsule was removed.As well, the customer reported that the patient had a known allergy to sulfur.The attached capsule visual investigation did not find any findings.However, per advising with medical advisor and bravo qe, it was found that sulfur is a known substance in the trocar needle, 0.15-0.35% of needle weight.(see attachment).Therefore, as agreed with medical affairs we can estimate that the most probable root cause is allergy to a component.The investigation found the device to function normally and within specifications.Per information provided by customer regarding patient's known allergies, patient's allergic reaction while going through bravo procedure and patient's symptoms stopping after capsule removal, the investigation found the probable root cause is patient's allergy to sulfur contained in bravo capsule, but since it cannot be determined that the sulfur caused the allergy a root cause was not identified.As per advised by the medical affairs the following statement has been added to the investigation: "it is important to note that in some cases, patients with a known allergy to sulfonamides will not have cross reactivity to sulfur contained in other compounds or devices.Therefore, it is not possible to conclude with absolute certainty that the patient¿s response was secondary to the sulfur content of the stainless-steel trocar.¿ if information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, customer called to report a patient with allergic reaction to capsule after placement.Patient called customer and informed swelling in eyes, face purplish red, itching (red all over), lips tingling and shortness of breath.Customer requested medical advice and would like to know if the bravo capsule has any sulfur.Patient had history with scleroderma and allergic to morphine sulfate, sulfa (sulfonamide antibiotics), prednisone, ciprofloxacin, plaquenil.The test only lasted for 24 hours because patient needed to come back to the hospital to have the capsule taken out.The patient felt better after the capsule was removed.

• 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, MA 55441 ; 7632104064
• MDR Report Key: 7172077
• MDR Text Key: 96628719
• Report Number: 9710107-2018-00060
• Device Sequence Number: 1
• Product Code: FFT
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 36079Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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