MAUDE Adverse Event Report: MED MICHIGAN HOLDINGS LLC / SURGE CARDIOVASCULAR SURGE CARDIOVASCULAR; ALPINE FEMORAL VENOUS CANNULA

Model Number FEM-V1024

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/13/2023

Event Type  Injury  

Event Description

It was reported by the customer the alpine femoral venous cannula 24fr had poor drainage during ecmo procedure and fractured in half during removal.No harm to patient.Ecmo procedure is not in accordance with the indications of use for this device.

• Brand Name: SURGE CARDIOVASCULAR
• Type of Device: ALPINE FEMORAL VENOUS CANNULA
• Manufacturer (Section D): MED MICHIGAN HOLDINGS LLC / SURGE CARDIOVASCULAR; 2140 oak industrial drive ne; grand rapids MI 49505
• Manufacturer (Section G): MED MICHIGAN HOLDINGS LLC / SURGE CARDIOVASCULAR; 2140 oak industrial drive ne; grand rapids MI 49505
• Manufacturer Contact: james wisniewski ; 2140 oak industrial drive ne; grand rapids, MI 49505 ; 6168211323
• MDR Report Key: 17273563
• MDR Text Key: 318577825
• Report Number: 3017540705-2023-00002
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081933
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FEM-V1024
• Device Catalogue Number: FEM-V1024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention