MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HST III SYSTEM (3.8MM); CLAMP, VASCULAR

Model Number HST III SYSTEM (3.8MM)

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2020

Event Type  malfunction  

Manufacturer Narrative

Trackwise id # (b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.

Event Description

The hospital reported that during a coronary artery bypass procedure, hs iii aortic cutter 3.8mm came out too far.They were able to finish the procedure and the patient was not harmed.

Manufacturer Narrative

D1,d2,d4 corrections: device info has been changed.Internal complaint number: (b)(4).

Event Description

The hospital reported that during a coronary artery bypass procedure, hs iii aortic cutter 3.8mm came out too far.They were able to finish the procedure and the patient was not harmed.

• Brand Name: HST III SYSTEM (3.8MM)
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 10136320
• MDR Text Key: 194609319
• Report Number: 2242352-2020-00496
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2021
• Device Model Number: HST III SYSTEM (3.8MM)
• Device Catalogue Number: HSK-3038
• Device Lot Number: 25150095
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 DA
• Patient Weight: 77