MAUDE Adverse Event Report: COVIDIEN LP BARRX BARRX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	FLEXCC-020A
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during the procedure for high grade dysplasia, the catheter failed to inflate.The catheter will be returned for investigation.Two weeks post procedure, the patient was admitted to the hospital for gastrointestinal bleeding from esophagus and was on anti-coagulant.
Additional Manufacturer Narrative
Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during the procedure of barrx for high grade dysplasia, the catheter failed to inflate.The catheter will be returned for investigation.Two weeks post procedure, the patient was admitted to the hospital for gastrointestinal bleeding from esophagus and was on anti-coagulant.The customer spoke with the physician and nurses and reported that the patient did not experience any harm due to the device malfunction.

• Brand Name: BARRX
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP BARRX; covidien gi solutions; sunnyvale CA 94085 4022
• MDR Report Key: 7940301
• Report Number: 3004904811-2018-00033
• Device Sequence Number: 11262227
• Product Code: GEI
• UDI-Device Identifier: 10884521181298
• UDI-Public: 10884521181298
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K083711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FLEXCC-020A
• Device Catalogue Number: FLEXCC-020A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 10/05/2018
• Supplement Report FDA Received Date: 11/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Weight: 95