MAUDE Adverse Event Report: MAQUET CV HS III PROXIMAL SEAL SYTEM 3.8MM; CLAMP, VASCULAR

Catalog Number C-HSK-3038

Device Problems Improper or Incorrect Procedure or Method (2017); Failure to Fire (2610)

Patient Problem Injury (2348)

Event Date 05/08/2018

Event Type  malfunction  

Manufacturer Narrative

(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 proximal seal system 3.8mm punch did not fire as expected by the surgeon.With further discussions, it appears there was miscommunication between the surgeon and staff.The safety was still 'on' and that was the issue.There was an unexpected injury to the tissue at the anastomotic site.The surgeon repaired the injury at the anastomotic site and completed the procedure.

Manufacturer Narrative

(b)(4).A lot history record review was completed for lot numbers 25135290, 25136275, and 25136763 the last 3 lots shipped to the account prior to the event date.There are no ncmr¿s which could be considered related to the reported event recorded in the lot history.

Event Description

The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 3.8mm punch did not fire as expected by the surgeon.With further discussions, it appears there was miscommunication between the surgeon and staff.The safety was still 'on' and that was the issue.There was an unexpected injury to the tissue at the anastomotic site.The surgeon repaired the injury at the anastomotic site and completed the procedure.

• Brand Name: HS III PROXIMAL SEAL SYTEM 3.8MM
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 7574953
• MDR Text Key: 110273141
• Report Number: 2242352-2018-00523
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• PMA/PMN Number: K080169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-HSK-3038
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other