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

Model Number	94975
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information that during use of a dlp silicone rcsp cannula with manual-inflate cuff, the customer reported a leak from the blue connection point.This was noticed immediately upon first use.The cannula was used under normal conditions with no unusual handling and sharp objects nearby.The device was used to complete the procedure.There was no adverse patient effect associated with this event.Medtronic received additional information that the leak was noticed at the stage when the retro cannula had been placed in position, meaning the cannula had been exposed to blood.The defective leak point was at the blue connection of the cannula, not in the parts inside the patient.The cannula was already placed in the patient and was not replaced, but the leaking area was taped during the procedure.The customer stated that due to the defect, the retro cannula had to be refilled several times.The defective cannula prolonged the duration of the surgery and made monitoring more difficult.
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
Device evaluation summary: visual inspection showed evidence of damage/cut in the cuff inflation tubing line.During the cleaning pr ocess there was a leak observed from the damaged line.The reason for the return was confirmed.Additional information b5: medtronic received additional information that the cannula was visually inspected, as per normal practice.The device was flushed with saline, as is routinely done.It was stated that there was no risk of bleeding.The duration of the procedure was prolonged by a few minutes by the issue.It was stated that the cannula was not replaced as the cannula was already in place and functioned adequately after it was tapped.When the issue was observed, the aorta had already been clamped, and it was considered preferable to avoid additional clamp time.Correction section d3 (mfr name), d3.1 (street 1), d3.3 (mfr city), d3.4 (mfr region) and d3.6 (postal code): these fields have been 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.

• Brand Name: 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: 24375300
• Report Number: 2184009-2026-00266
• Device Sequence Number: 5676015
• Product Code: DWF
• UDI-Device Identifier: 00643169454835
• UDI-Public: (01)00643169454835(17)271213(10)80035417
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K953945
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 94975
• Device Catalogue Number: 94975
• Device Lot Number: 80035417
• 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: 02/09/2026
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown