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 Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pulmonary Embolism (1498)

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.Device discarded.

Event Description

The hospital reported through doc matter about the vessel harvesting tool used for an endoscopic vein harvesting procedure regarding co2 embolism.Thankfully when it does occur most of the time it is not of consequence.Over my career it has only happened once again without consequence, but really scary at the time.We must always be watchful of the cvp pressure and what setting our gas pressure is at, the ifu in every hemopro kit specifically states the min and maximum setting, i encourage all to follow the ifu in that regard." the event of suspected co2 embolism occurred roughly 15 years ago.The device being used at the time was the vasoview 4.He does not recall if he had told his evh representative at the time.He states he only uses two setting for the insufflator 8mmhg for pressure and 3 l/min flow and if there is no tunnel he increases the numbers to 10mmhg and 5 l/min.In regards to this complaint, the only evidence of a potential embolism was that a large cauterized and ligated branch stump on the patient side was opening and closing in what he felt was along with the co2 flow.There was no evidence of air bubbles seen in the right atrium on direct inspection.There was no change in the patients hemodynamics.Out of the abundance of caution he states he had turned off theco2 insufflator for a short time to make sure there was no patient adverse effect.The patient remained stable and he then continued and completed the procedure using the lower pressure setting.Post-operatively there were no adverse events for the patient.

Manufacturer Narrative

Trackwise #: (b)(4).Analysis of production: no device was reported, therefore a lot history review is unavailable.Trend analysis: no complaint data is available as there was no specific product reported.Communication/interviews: (4111/213/67) communication/interviews were performed to obtain all possible information.

Event Description

N/a.

• 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: 13994845
• MDR Text Key: 288483234
• Report Number: 2242352-2022-00287
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• 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: 05/03/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Outcome(s): Required Intervention