MAUDE Adverse Event Report: MEDTRONIC, INC. ATTAIN VENOGRAM BALLOON CATHETER; CATHETER, FLOW DIRECTED

Model Number	6215
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that prior to the procedure, the balloon catheter was tested and did not inflate or deflate properly.The catheter was not used.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the balloon catheter was returned, analyzed, and no anomalies were found.The analyst noted the balloon catheter was returned without the inflation syringe.The balloon catheter was able to inflate with a 1.25 ml syringe and hold its inflation and the balloon deflated as expected.There were no anomalies found with the balloon on the balloon catheter at this time.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATTAIN VENOGRAM BALLOON CATHETER
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 10320730
• Report Number: 2182208-2020-01349
• Device Sequence Number: 11507915
• Product Code: DYG
• UDI-Device Identifier: 00613994842114
• UDI-Public: 00613994842114
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K012225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/25/2021
• Device Model Number: 6215
• Device Catalogue Number: 6215
• Device Lot Number: 0061698581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 08/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1