MAUDE Adverse Event Report: MC3 INC. MC3; DUAL LUMEN ECMO CANNULA

Model Number	70132
Medical Device Problem Codes	Crack (1135); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: visual inspection showed evidence of a split in the cannula body at the location of the sutures.The reason for return was confirmed.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 crescent jugular dual lumen catheter was observed to have a crack below the gold wire reinforced section, with the cannula completely cracked all the way through during use.Air entrainment was heard after the patient was turned on their side.The damage was located in the area of the sutures.The hemostasis cap was used when the introducer was inserted into the cannula body connector.The catheter required replacement at the bedside, and extra corporeal membrane oxygenation (ecmo) was re-initiated.No patient complications have been reported as a result of this event.Medtronic received additional information that the necessary intervention was to replace the cannula.The same size cannula was plac ed in the same anatomical site and in the same position.They noticed that the white suture ring was not used in this procedure.Medtronic received additional information that the cannulation date was (b)(6) 2025.This was the first catheter used in the case.The patient was on ecmo for 17 days prior to the air entrainment.The insertion site was inspected, checked and cleaned daily and as per the nursing shift.There was no air detection in the circuit (pre-oxy, post-oxy, or other).The sutures were located on the wire portion.The sutures were not located on the gold section or on the silicone ring.A training will be held to remind the staff on how to safely secure this cannula.The patient was not ambulant.This situation occurred after they rotated the patient for cleaning or for a bed sheet change.
Additional Manufacturer Narrative
Additional information h6.4 eval code conclusion (fdc/annex d): this field was 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: MC3
• Common Device Name: DUAL LUMEN ECMO CANNULA
• Manufacturer (Section D): MC3 INC.; 2555 bishop circle west; dexter MI 48130
• Manufacturer (Section G): MC3 INC.; 2555 bishop circle west; dexter MI 48130
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 22507370
• Report Number: 3011468686-2025-00050
• Device Sequence Number: 13112191
• Product Code: PZS
• UDI-Device Identifier: 10854916006826
• UDI-Public: (01)10854916006826(17)260430(10)2304275
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K180151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: 70132
• Device Catalogue Number: 70132
• Device Lot Number: 2304275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2023
• 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 Sex: Unknown