MAUDE Adverse Event Report: GETINGE / MAQUET CARDIOVASCULAR LLC. HEARTSTRING III PROXIMAL SEAL SYSTEM; CLAMP, VASCULAR

Model Number HSK-3038

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 01/02/2023

Event Type  malfunction  

Event Description

Upon activation of the aortic cutter portion of the device, it was observed that the seam of the plastic body of the cutter had separated.

• Brand Name: HEARTSTRING III PROXIMAL SEAL SYSTEM
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): GETINGE / MAQUET CARDIOVASCULAR LLC.
• MDR Report Key: 16113917
• MDR Text Key: 306905967
• Report Number: MW5114207
• 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: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2023
• Device Model Number: HSK-3038
• Device Catalogue Number: HSK-3038
• Device Lot Number: 3000272194
• 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: 80 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White