MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC. HEART[INVALID]III PROXIMAL SEAL SYSTEM; CLAMP, VASCULAR

Model Number HSK-3038

Device Problems Retraction Problem (1536); Material Separation (1562)

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

Event Date 12/05/2022

Event Type  malfunction  

Event Description

When scrub person took heart [invalid]aortic cutter back from surgeon, they noticed that the 2 plastic parts that create the shaft of the device were separated, and that the actuation button had fully retracted into the device.

• Brand Name: HEART[INVALID]III PROXIMAL SEAL SYSTEM
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC.; wayne NJ 07470
• MDR Report Key: 15940716
• MDR Text Key: 305161412
• Report Number: MW5113697
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2023
• Device Model Number: HSK-3038
• Device Catalogue Number: HSK-3038
• Device Lot Number: 3000269566
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White