MAUDE Adverse Event Report: MEDTRONIC DEXTER (MC3 INC.) CRESCENT RA 13 FR; DUAL LUMEN ECMO CATHETER

Model Number	70413
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Codes	Insufficient Information (4580); Reduced Blood Flow (4598)
Date of Event	03/26/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device was not returned for evaluation.The root cause of the reported crack in the catheter is unknown.Based on the user's description, one possible cause of the crack is suturing to the catheter body.There are designated suture sites on the catheter; however, if the user applies sutures to the wire reinforced region of the catheter body, it is possible to damage the catheter.
Event or Problem Description
On (b)(6) 2024, a female newborn (36 hours old, weight 3.4 kg), 38 week delivery with meconium aspiration, was cannulated with a crescent ra 13 fr catheter to the ij using an open cut-down technique.The patient was paralyzed and sedated.Approximately 5 minutes after ecmo was initiated, a crack was noticed just below the gold suture ring causing air entrainment and the inability to flow through the ecmo circuit.Sutures were present on the cannula body.It was reported that a new catheter was unable to be placed due to the surgeon being unable to push a second catheter past 4 cm such that the ecmo therapy was not continued.The patient was reported as deceased.Date of death is (b)(6) 2024.Cause of death is unknown.

• Brand Name: CRESCENT RA 13 FR
• Common Device Name: DUAL LUMEN ECMO CATHETER
• Manufacturer (Section D): MEDTRONIC DEXTER (MC3 INC.); 2555 bishop circle west; dexter MI 48130
• Manufacturer (Section G): MEDTRONIC DEXTER (MC3 INC.); 2555 bishop circle west; dexter MI 48130
• Manufacturer Contact: martha rumford ; 2555 bishop circle west; dexter, MI 48130 ; 7349959089
• MDR Report Key: 19168442
• Report Number: 3011468686-2024-00012
• Device Sequence Number: 7324459
• Product Code: PZS
• UDI-Device Identifier: 10850007732209
• UDI-Public: (01)10850007732209(17)251031(10)2210156
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Model Number: 70413
• Device Lot Number: 2210156
• 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: 03/27/2024
• Initial Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2023
• 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: Death
• Patient Age: 1 DA
• Patient Sex: Female
• Patient Weight: 3 KG