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

Model Number	6215
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that the physician was unable to flush the balloon catheter.After depressing the syringe's plunger, the saline was unable to flow through the catheter.This resulted in a build-up of pressure that suddenly released and sprayed saline back into the physician's eyes and face.The physician temporarily left the case to flush their eyes and wash their face.A guidewire was attempted to be fed through the catheter's flush port with no success due to an unknown resistance or occlusion.It was noted that the balloon was able to be inflated and deflated properly.A different catheter was used to complete the procedure. no patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary the balloon catheter was returned and analyzed.Returned product analysis was performed and no anomalies were found.There was a mec hanical issue with the syringe.Visual analysis of the balloon indicated damage during use.The analyst noted the balloon catheter was returned with the inflation syringe affixed to the balloon inflation port of the balloon catheter.There was saline in the inflation syringe of the balloon catheter.The balloon of the balloon catheter was able to be inflated and deflated as expected.A fresh 0.014 guidewire was able to be fully inserted and passed through the balloon catheter without restriction.The balloon catheter was able to be flushed without restriction with a syringe and water affixed to the infusion port of the balloon catheter.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was further reported that the event occurred prior to the catheter being inserted into the patient¿s body.The catheter testing was conducted on the surgical table alongside other operating tools and instruments.The physician was sprayed with the syringe¿s contents which was saline; however, bodily fluids were surrounding the working environment and could have cross contaminated.Details were confirmed after the procedure.

• 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
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 19077709
• Report Number: 2182208-2024-01557
• Device Sequence Number: 20341039
• Product Code: DYG
• UDI-Device Identifier: 00763000227982
• UDI-Public: 00763000227982
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K012225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2024

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: 05/23/2025
• Device Model Number: 6215
• Device Catalogue Number: 6215
• Device Lot Number: 23E23844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2024
• Supplement Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male