MAUDE Adverse Event Report: MEDTRONIC GRAND RAPIDS MANUAL INFLATE RCSP RETROGRADE CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	94115T
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that prior to use of a gundry silicone rcsp cannula with manual-inflate cuff, it was reported that it could not be inflated properly.The use of the device was unknown.There was no patient involvement, so no adverse effect occurred.
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.
Additional Manufacturer Narrative
Correction b.5: medtronic received information that during use of a gundry silicone rcsp cannula with manual-inflate cuff, it was reported that it could not be inflated properly.The use of the device was unknown.There were no reported adverse patient effects.Correction d.3 mfr name, street 1, mfr city, mfr region & postal code.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.

• Brand Name: MANUAL INFLATE RCSP RETROGRADE CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
• Manufacturer (Section D): MEDTRONIC GRAND RAPIDS; 620 watson sw; grand rapids,mi MN 49504
• Manufacturer (Section G): MEDTRONIC GRAND RAPIDS; 620 watson sw; grand rapids,mi MN 49504
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 23919781
• Report Number: 2184009-2025-01670
• Device Sequence Number: 13032171
• Product Code: DWF
• UDI-Device Identifier: 00643169454521
• UDI-Public: (01)00643169454521(17)271006(10)2024100356
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 03/31/2026

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: 94115T
• Device Catalogue Number: 94115T
• Device Lot Number: 2024100356
• 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: 12/24/2025
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2024
• 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