MAUDE Adverse Event Report: MEDTRONIC INC/ MC3 INC MC3 (32FR CRESCENT); DUAL LUMEN ECMO CANNULA

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 06/15/2021

Event Type  malfunction  

Event Description

Patient was taken to the cath lab with dr.Patient was hooked to monitor, prepped and draped per usual.Dr.Obtained ij access and dilated, when inserting cannula he met resistance.He then attempted to pull cannula and was unable.During this attempt it was noted by those in the room that excessive force was used to insert and attempt to remove.(perfusionist) called dr.For assistance.Dr.Removed the cannula and held pressure on site.The cannula was inspected and saved.(perfusionist) contacted the company and will be returning the line to them.Fda safety report id # (b)(4).

• Brand Name: MC3 (32FR CRESCENT)
• Type of Device: DUAL LUMEN ECMO CANNULA
• Manufacturer (Section D): MEDTRONIC INC/ MC3 INC
• MDR Report Key: 12059266
• MDR Text Key: 258699015
• Report Number: MW5102122
• Device Sequence Number: 1
• Product Code: DWF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/22/2021

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
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/23/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 76