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

Model Number	94735
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during use of the dlp silicone rcsp cannula with an auto-inflate cuff, the white clip on the cannula line pierced the silicone and created a hole.The surgeon was required to plug the hole with a finger during cardioplegia administration.There was no metal clamp used on the line and the piercing resulted purely from the application of the clip.The device was used to complete the procedure.Whether there were any adverse patient effects associated with this event is unknown.Medtronic received additional information that there was no patient impact.Leak was from the body of the cannula.The cannula was not heated or cooled prior to use.The damage was where the white clip on the cannula line was placed.Minimal blood loss, the surgeon was able to plug the hole with their finger, and no transfusion was needed.
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: visual inspection shows evidence of damage/tear in the cannula at the clamp location.The device was attached to a syringe filled with deionised water water and when it was engaged there was a leak observed from the damaged/tear location.Conclusion: reason for the return was confirmed.H.6.Update to fdd,fdm and fdr codes 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): 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: 22574598
• Report Number: 2184009-2025-00870
• Device Sequence Number: 18562326
• Product Code: DWF
• UDI-Device Identifier: 00643169454750
• UDI-Public: (01)00643169454750(17)271229(10)0230319206
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K123762
• 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): 09/03/2025

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: 94735
• Device Catalogue Number: 94735
• Device Lot Number: 0230319206
• 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: 06/26/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/29/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown