MAUDE Adverse Event Report: PERFUSION SYSTEMS GUNDRY; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	94715
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that prior to use of a gundry silicone rcsp cannula with a manual-inflate cuff, the balloon did not inflate properly when the surgeon attempted to use the cannula.The device was replaced by another medtronic device to complete the procedure.There was no patient involvement, so no adverse effect occurred.Medtronic received additional information that a leak was not observed anywhere on the device.There was no damage to the device or balloon.The customer stated that the issue was that the balloon did not inflate all the way.One end of the balloon was inflated ¾ and the other end was inflated ¼.The doctor checked 3 cannulae before inserting into to the patient.Medtronic received additional information that the customer observed the issue when performing the water test.The balloon was inflating ¾ from 1 corner and ¼ from the other corner which normally the inflating should be centrally.
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Correction: b5 updated.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
Medtronic received information that prior to use of three gundry silicone rcsp cannulae with a manual-inflate cuff, the balloons did not inflate properly when the surgeon attempted to use the cannulae.The devices were replaced by another medtronic device to complete the procedure.There was no patient involvement, so no adverse effect occurred.Medtronic received additional information that a leak was not observed anywhere on the devices.There was no damage to the devices or balloons.The customer stated that the issue was that the balloons did not inflate all the way.One end of the balloons was inflated ¾ and the other end was inflated ¼.The doctor checked 3 cannulae before inserting into to the patient.Medtronic received additional information that the customer observed the issue when performing the water test.The balloons were inflating ¾ from 1 corner and ¼ from the other corner which normally the inflating should be centrally.

• Brand Name: GUNDRY
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 21398121
• Report Number: 2184009-2025-00215
• Device Sequence Number: 7586195
• Product Code: DWF
• UDI-Device Identifier: 00643169454712
• UDI-Public: 00643169454712
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K860149
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2025

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: 94715
• Device Catalogue Number: 94715
• Device Lot Number: 2024080587
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 05/08/2025
• Date Device Manufactured: 10/24/2024
• 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 Sex: Unknown