MAUDE Adverse Event Report: MC3 INC. CRESCENT RA DUAL LUMEN CATHETER 15 FR; DUAL LUMEN ECMO CANNULA

Model Number	70415
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, an active 5 month old female patient was cannulated through the ij with a 15 fr crescent ra dual lumen catheter.It was reported sutures were placed around the gold suture ring and the bifurcation.On (b)(6) 2022, after a nurse observed micro bubbles and a fracture to the cannula, the patient was taken to the operating room where the cannula was replaced to the ij.There was no patient impact.
Additional Manufacturer Narrative
Device evaluation found a kink at the fracture.Furture evaluation suggests a suture was tied near the fracture.
Additional Manufacturer Narrative
Additional information received 17-jan-2023, 3011468686-2022-00020 and 3011468686-2022-00022 are the same patient.
Event or Problem Description
Additional information received indicated 3011468686-2022-00020 and 3011468686-2022-00022 are the same patient.The patient, confirmed to be 8 months old, with a history of bronchopulmonary dysplasia was treated with ecmo.On (b)(6) 2022, the patient was initially cannulated.On (b)(6) 2022 and (b)(6) 2022, the patient was re-cannulated through the right ij.The patient was not sedated.On (b)(6) 2022, the patient was decannulated.

• Brand Name: CRESCENT RA DUAL LUMEN CATHETER 15 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: 16036277
• Report Number: 3011468686-2022-00020
• Device Sequence Number: 5450359
• Product Code: PZS
• UDI-Device Identifier: 10850007732216
• UDI-Public: (01)10850007732216(17)241031(17)2110102
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K203409
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/08/2024

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: 10/31/2024
• Device Model Number: 70415
• Device Catalogue Number: 70415
• Device Lot Number: 2110102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2022
• Supplement Date Received by Manufacturer: 01/17/2023; Not provided
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 02/10/2023; 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2022
• 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 Age: 8 MO
• Patient Sex: Female