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

Model Number	6215
Medical Device Problem Codes	Break (1069); Burst Container or Vessel (1074); Device Contamination with Body Fluid (2317); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the balloon catheter was returned and analyzed.The analysis indicated that the mechanical operation of the balloon catheter was occluded.There was an issue with the catheter shaft.The balloon was ruptured.Blood was observed on the shaft of the delivery catheter.Visual analysis of the balloon catheter indicated damage during use.The analyst noted the balloon catheter was returned without the inflation syringe and the coronary wire.There is blood at the distal tip orifice of the balloon catheter.The balloon is ruptured on the balloon catheter.A guidewire was inserted into the balloon catheter and came to an occlusion at 39 cm.Blood and contrast occluded the shaft of the balloon catheter.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during an implant procedure, the balloon catheter would not allow the coronary wire to pass through and exit the catheter lumen.The catheter was not used and another was used.The catheter was returned to the manufacturer, analyzed, and tested out of specification.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: 10311045
• Report Number: 2182208-2020-01329
• Device Sequence Number: 804010
• Product Code: DYG
• UDI-Device Identifier: 00613994842114
• UDI-Public: 00613994842114
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K012225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/22/2020

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 Model Number: 6215
• Device Catalogue Number: 6215
• Device Lot Number: 6215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR