MAUDE Adverse Event Report: MC3 INC. CRESCENT JUGULAR DUAL LUMEN CATHETER 30 FR.; DUAL LUMEN ECMO CANNULA

Model Number	70130
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mc3 investigated the returned device.The point in question was examined and tested.The catheter was not fractured.It was confirmed that there was evidence of wire delamination at the outer surface of the catheter.The inside surface of the outer drainage lumen at the point in question was intact.This is consistent with the report that this was a planned exchange after 60 days of ecmo use.The wire protrusion occurred due to repetitive bending/kinking in the same location over time which is concluded to be fatigue of the urethane material that covers the wire.There was no metal fatigue but some misalignment of the spring coils due to the bending stresses.There were a few surface irregularities upon inspection of the infusion lumen surface which were discovered unrelated to the complaint and its source was not confirmed.There was also visible evidence of scratch marks from a sharp object on the outer catheter body on a different location than the point in question.It is concluded that the wire protrusion observed was a result of catheter bending fatigue.
Event or Problem Description
The distributor, (b)(4), reported a complaint from a customer who reported this information to mc3.The customer had a patient on veno-venous ecmo for 60 days and then did a planned catheter exchange.There was no direct patient impact.Upon looking at the catheter after the catheter was exchanged, the customer noticed that there was some exposure of the wire on the catheter.The customer reported that they did not use the provided suture collar but stated they sutured on the gold ring.They stated that they use a velcro head wrap to secure the catheter to the patient.The information stated that they try to ambulate the patient and there is some manipulation of the lines and catheter over time.

• Brand Name: CRESCENT JUGULAR DUAL LUMEN CATHETER 30 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: martha rumford ; 2555 bishop circle west; dexter, MI 48130 ; 7349959089
• MDR Report Key: 13592942
• Report Number: 3011468686-2022-00004
• Device Sequence Number: 17620411
• Product Code: PZS
• UDI-Device Identifier: 10854916006819
• UDI-Public: 10854916006819
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 70130
• Device Catalogue Number: 70130
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 02/24/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown