MAUDE Adverse Event Report: MC3 INC. CRESCENT RA DUAL LUMEN CATHETER, 15FR; 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	12/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The fracture was confirmed during device evaluation, possible cause due to repeat bending adding stress to cause a kink resulting in the fracture, due to the patient being very active and unsedated.As noted in the ifu circuit lines should be managed throughout treatment to reduce catheter flexing, kinking or dislodgement.The kink was not noticed until the fracture occurred.
Event or Problem Description
On (b)(6) 2022, an 8 month old patient was cannulated with a 15 fr crescent ra dual lumen catheter.The patient was described as being very active and not sedated.On (b)(6) 2022, the patient was off ecmo for a brief period of time during exchange procedure due to reported catheter fracture.The patient did not experience any injury.
Additional Manufacturer Narrative
Follow up report for additional information in b1(adverse event), b4 (date of report), d4 (added expiration date).Correction to g1 (contact information), and h1 (change from malfunction to serious injury).

• Brand Name: CRESCENT RA DUAL LUMEN CATHETER, 15FR
• Common Device Name: DUAL LUMEN ECMO CANNULA
• Manufacturer (Section D): MC3 INC.; 2555 bishop circle; 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: 16148086
• Report Number: 3011468686-2022-00022
• Device Sequence Number: 15153952
• Product Code: PZS
• UDI-Device Identifier: 10850007732216
• UDI-Public: (01)10850007732216(17)250430(10)2204239
• 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
• 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: 04/30/2025
• Device Model Number: 70415
• Device Catalogue Number: 70415
• Device Lot Number: 2204239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2022
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2023
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 8 MO
• Patient Sex: Unknown
• Patient Weight: 6 KG