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

Model Number	6215
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2018
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 analysis of the catheter indicated damage during use.The analyst noted the guidewire returned with the catheter stops backloading at 30.5 cm from the distal tip of the catheter due to occlusion of contrast.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 indicated there was difficulty introducing the guidewire into the balloon catheter.After introduction of the wire into the catheter, the guidewire became stuck at the distal end/tip of the balloon catheter.Introducing the wire by front loading allowed the wire to pass in and out of the tip with no noted issue.The catheter was removed.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: 7529660
• Report Number: 2182208-2018-00953
• Device Sequence Number: 1425331
• Product Code: DYG
• UDI-Device Identifier: 00613994842114
• UDI-Public: 00613994842114
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2018

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: 08/21/2019
• Device Model Number: 6215
• Device Catalogue Number: 6215
• Device Lot Number: 0061577313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 05/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1