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

Model Number	6215
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the balloon catheter was returned and analyzed.The mechanical operation of the balloon catheter was occluded.Visual summary analysis of the catheter indicated damage during use.The analyst noted a test sample guidewire was inserted but stopped at 19.5 cm due to crystallized saline.Once the lumen was flushed with alcohol, the guidewire was fully inserted with no anomaly.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during the implant procedure, the physician could not get the wire through the tip of the balloon catheter.The catheter was used for the procedure.No patient complications have been reported as a result of this event.

• 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: 8805911
• Report Number: 2182208-2019-01307
• Device Sequence Number: 457173
• Product Code: DYG
• UDI-Device Identifier: 00613994842114
• UDI-Public: 00613994842114
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 07/18/2019

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: 11/06/2020
• Device Model Number: 6215
• Device Catalogue Number: 6215
• Device Lot Number: 0061628442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 07/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR