MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VASOVIEW HEMOPRO 2

Device Problem Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2022

Event Type  malfunction  

Manufacturer Narrative

Trackwise id (b)(4).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro 2, attempting to dissect the greater saphenous vein and was being alerted by high co2 pressure and having no tunnel.They tried to trouble shoot by checking the co2 tubing plugged into the port and she switched out the co2 tubing with no help.They switched out to a new vh-4000 and was able to complete the case.Believes the issue lies within the btt port.The hospital did not report any patient effects.

Manufacturer Narrative

Trackwise (b)(4).Analysis of production: (3331/213/67) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure mode.Historical data analysis: (4109/213/67)the review of the historical data indicates that no other similar complaints was reported for the same lot number and reported failure mode.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period feb 2020 through jan 2022 was reviewed.There were no triggers identified for the review period.Communication/interviews: (4111/213/67) communication/interviews were performed to obtain all possible information.Testing of actual/suspected device : (10 /213/67).The device was returned to the factory for evaluation on 02/24/2022.An investigation was conduced on 03/02/2022.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed on the btt.There were no visual defects observed on the btt.A mechanical evaluation was conducted.A 5cc syringe, filled with saline was attached to the co2 line on the btt and squeezed the syringe to spray the saline.No leaks were observed on the silicone balloon.The btt was able to be inflated.Based on the returned condition of the device, and the investigation results, the reported failure "inflation problem" was not confirmed.

• Brand Name: VASOVIEW HEMOPRO 2
• 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: 13768731
• MDR Text Key: 289509644
• Report Number: 2242352-2022-00218
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700406
• UDI-Public: 00607567700406
• Combination Product (y/n): N
• PMA/PMN Number: K101274
• 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: Followup
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2023
• Device Model Number: VASOVIEW HEMOPRO 2
• Device Catalogue Number: C-VH-4000
• Device Lot Number: 25161862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 125 KG