MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC PRODUCT NOT IN LIST - VESSEL HARVESTING; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number PRODUCT NOT IN LIST - VESSEL HARVESTING

Device Problems Improper Flow or Infusion (2954); No Apparent Adverse Event (3189)

Patient Problems Embolism/Embolus (4438); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

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

In a docmatter platform post the customer mentions experience with a co2 embolism.Holes were at the sf junction.Once the repair was made, they stapled the hole closed and continued with evh.No description of patient harm within the post.

Manufacturer Narrative

Trackwise id # (b)(4).Corrected section: h-6 from '2954" to "3189".

• Brand Name: PRODUCT NOT IN LIST - VESSEL HARVESTING
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 15279134
• MDR Text Key: 298436622
• Report Number: 2242352-2022-00715
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRODUCT NOT IN LIST - VESSEL HARVESTING
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention