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

Model Number	70124
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during insertion of an mc3 crescent cannula, it was reported that the connector on the return connection was cracked.The hemostasis cap was used when the introducer was inserted into the cannula body connector.The return (arterial) connector was cut out and replaced with another 3/8x3/8 straight connector to complete the procedure.There was no adverse patient effect associated with this event.Medtronic received additional information that the customer stated this was an urgent cannulation.The patient was weaned from support.Medtronic received additional information that the exact location of the crack on the cannula was on the arterial (return) side of the cannula.The crack was noticed on insertion into the patient.Medtronic received additional information that the customer stated that the connector was cracked on the connector glue joint side.
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.

• 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: 20798137
• Report Number: 3011468686-2024-00038
• Device Sequence Number: 20828294
• Product Code: PZS
• UDI-Device Identifier: 10854916006789
• UDI-Public: 10854916006789
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/27/2024

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: 06/30/2025
• Device Model Number: 70124
• Device Catalogue Number: 70124
• Device Lot Number: 2206164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 11/27/2024
• Date Device Manufactured: 06/30/2022
• 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 Sex: Prefer Not To Disclose