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

Model Number	70132
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	05/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation summary: the customer's observation of a fracture at the maximum insertion mark was confirmed during complaint device evaluation.The catheter was kinked at the breach site.A suture was found on the device, tied directly to the catheter body in the wire reinforcement section.Longitudinal cut marks were also found on the catheter.The ink for labeling the french size and clampable section of the catheter was faded.Note: this event was initially reported by mc3 inc.Under report #3011468686-2022-00009.This report is being submitted to correct the below fields: b1: report type updated to adverse event product problem.B2: outcome attributed to adverse event updated.B5: updated.H1: type of reportable event updated to serious injury.H6: codes 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 during use of a mc3 crescent jugular catheter, the customer reported that while preparing to decannulate the crescent catheter from the patient, customer noticed the catheter had a gurgling sound.Upon visual examination they observed the crescent catheter was fractured, thus necessitating immediate cessation of extra-corporeal membrane oxygenation (ecmo) flow.The device had been used to complete the procedure.There was no patient impact associated with this event.Additional information was received that after decannulation of the crescent catheter, the surgeon performed an emergent insertion of cvc with swan-ganz catheter assisted air embolism extraction due to acute air embolism secondary to crescent catheter fracture.The patient anatomy did not contribute to the issue.Medtronic received additional information stating that the device was used for 30 plus days and the standard insertion technique was percutaneous in the right internal jugular was used.

• 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: 21968952
• Report Number: 3011468686-2025-00029
• Device Sequence Number: 8492584
• Product Code: PZS
• UDI-Device Identifier: 10854916006826
• UDI-Public: 10854916006826
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 05/06/2025

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 Expiration Date: 01/31/2025
• Device Model Number: 70132
• Device Catalogue Number: 70132
• Device Lot Number: 2201214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2022
• 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: Male