MAUDE Adverse Event Report: MC3 INC. CRESCENT JUGULAR DUAL LUMEN ECMO CATHETER 28 FR; DUAL LUMEN ECMO CANNULA

Model Number	70128
Medical Device Problem Codes	Use of Device Problem (1670); Air/Gas in Device (4062)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	12/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The catheter was not returned for analysis.Review of the information suggests the placement or securement of the catheter in the right subclavian may be a factor in this device experience.Placement of the catheter in the right subclavian is an unintended use of the device.A definitive root cause of the problem could not be confirmed with the information available.
Event or Problem Description
On an unknown date, a 62 year old male was cannulated in the right subclavian with a 32 fr crescent catheter.On (b)(6) 2023, two bedside cvicu rns contacted perfusion for assist in a patient clean/bathing/sheet exchange.Patient was log rolled, and air was pulled into the venous cannula.The circuit was clamped to draw the air out.-the patient's spo2 desaturated to the upper 80s.Afterwards, flows were resumed without harm to the patient and circuits were operating appropriately.Reference medwatch report # 520177000-2023-8011.
Event or Problem Description
This is a follow up to the previous report 3011468686-2023-00004.Additional information indicated the patient's weight was 78.3 kg.On (b)(6) 2022, the patient was cannulated in the right internal jugular with a 32 fr crescent catheter.On (b)(6) 2022 at 1453, the patient was weaned off ecmo and decannulated.On (b)(6) 2022, the patient decompensated.At 1802 the patient was re-cannulated in the right subclavian with a 28 fr crescent catheter (previously reported as a 32 fr catheter) utilizing a seldinger technique and ecmo was reinitiated for the treatment of decompensated respiratory failure.The catheter was placed under fluoroscopic guidance and was secured in place with multiple 0 ethibond sutures to prevent migration.Sterile dressings were applied.On (b)(6) 2022 (previously reported as (b)(6) 2023), the catheter was replaced with a 28 fr crescent catheter to the right internal jugular due to air entrainment from an unknown source.On (b)(6) 2023, the patient was restless.Chest x-ray confirmed catheter migration.It was reported the catheter was secured in four locations to the patient.The catheter was replaced with a 28 fr crescent catheter in the right internal jugular.No adverse effects were noted from the catheter migration and re-cannulation.On (b)(6) 2023, the patient expired.
Additional Manufacturer Narrative
The catheter was not returned for analysis.The reporter indicated the unknown source of air entrainment was thought to have occurred due to a "track" that was made from the catheter line and the hole in the vessel increased at the insertion site, thus resulting in air entrainment.The reporter also indicated the migration of the catheter may have resulted from the patient's restless behavior.The reporter did not claim a device malfunction.
Additional Manufacturer Narrative
Follow up report for additional information in b1(adverse event), b4 (date of report), d4 (added udi and expiration date).Correction to d3 and g1 (contact information), and h1 (change from malfunction to serious injury).

• Brand Name: CRESCENT JUGULAR DUAL LUMEN ECMO CATHETER 28 FR
• 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: tanya pockrandt ; 2555 bishop circle west; dexter, MI 48130 ; 7349959089
• MDR Report Key: 16637748
• Report Number: 3011468686-2023-00004
• Device Sequence Number: 5219944
• Product Code: PZS
• UDI-Device Identifier: 10854916006802
• UDI-Public: (01)10854916006802(17)240930(10)2109196
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/09/2024

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: 09/30/2024
• Device Model Number: 70128
• Device Lot Number: 2109196
• 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: 03/07/2023
• Supplement Date Received by Manufacturer: 04/20/2023; Not provided
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 05/17/2023; 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 62 YR
• Patient Sex: Male
• Patient Weight: 78 KG