MAUDE Adverse Event Report: MC3 INC. CRESCENT JUGULAR DUAL LUMEN CATHETER 32 FR

Model Number	70132
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Brain Injury (2219)
Date of Event	10/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Mc3 was made aware of this event via medwatch report from user (report mw5105171, received by manufacturer from fda on14dec2021) which described a catheter break after the patient was supported for 50 days on ecmo.According to event as reported, there was an air bubble detection alarm triggered.It is not known if the detection of the bubble stopped circulatory support.The report also stated that the catheter broke and necessitated surgical intervention to continue ecmo.During this surgery the patient suffered an anoxic brain injury.The exact cause of injury is not clear from the information provided.The report stated that the patient was resuscitated successfully and ecmo restarted after this event but then patient family withdrew care which resulted in death.Mc3 is working with the distributor to obtain more details about the event as reported.
Event or Problem Description
Ecmo cannula (at 50 days) developed a hairline crack which allowed air to be entrained in the system.When the bubble detector alarmed the perfusionist contacted the physician who came and took patient to operating room to change out.Patient arrested during this time and suffered an anoxic brain injury.Was resuscitated successfully.Patient's family withdrew care on (b)(6) 2021 and patient passed.

• Brand Name: CRESCENT JUGULAR DUAL LUMEN CATHETER 32 FR
• Common Device Name: DUAL LUMEN CATHETER 32 FR
• 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: martha rumford ; 2555 bishop circle west; dexter, MI 48130 ; 7349959089
• MDR Report Key: 13239928
• Report Number: 3011468686-2021-00018
• Device Sequence Number: 19972034
• Product Code: PZS
• UDI-Device Identifier: 10854916006826
• UDI-Public: (01)10854916006826(17)240331(10)2102173
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/07/2022

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?: No
• Operator of Device: Other
• Device Model Number: 70132
• Device Catalogue Number: 70132
• Device Lot Number: 2102173
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2021
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown