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

Model Number	70132
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: visual inspection of the 1 returned device shows evidence of use.Reason for return was undetermined.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 cannula, it was reported that upon insertion of 32 fr crescent cannula the customer observed a crack at the return port roughly 1-2 cm.The customer stated that they believe this may have been caused by torque or tension during placement and that the cannula could have been bent during insertion.The customer stated that there was no noted damage to the package or cannula prior to insertion.There was no damage at the location of the sutures.There was no reported blood loss to the patient.The device was replaced to complete the procedure.There was no adverse patient effect associated with this event.Medtronic received additional information that during an insertion the customer had trouble with the device.The customer was not sure if the tension, torque or elements with resistance caused the compromise at the port.The customer did use a 30 that was also removed, it was not challenged.The patient was placed on veno-venous arterial extracorporeal membrane oxygenation (vv-a ecmo), no issues were observed.
Additional Manufacturer Narrative
Medtronic received additional information that customer states that a 30 fr crescent was also placed and removed but per the customer there was no issue with the 30 fr crescent.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 of the returned device found a crack at the return port.Diameter measurements were checked and all dimensions were within specification.Reason for return was confirmed.Additional information h6.3 eval code result (fdr/annex c): this field was updated.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: 20798123
• Report Number: 3011468686-2024-00039
• Device Sequence Number: 20781338
• Product Code: PZS
• UDI-Device Identifier: 10854916006826
• UDI-Public: 10854916006826
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 03/04/2025

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: 03/31/2025
• Device Model Number: 70132
• Device Catalogue Number: 70132
• Device Lot Number: 2203215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 11/26/2024; 02/18/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 12/05/2024; 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2022
• 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
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Sex: Male
• Patient Weight: 110 KG