MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2 (W/VASOSHIELD); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VASOVIEW HEMOPRO 2 (W/VASOSHIELD)

Device Problem Inflation Problem (1310)

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

Event Date 05/09/2022

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

Related to (b)(6).The hospital reported that during an endoscopic vein harvesting procedure while harvesting the saphenous vein the vasoview hemopro 2 (w/vasoshield) during the initial dissection process, they inserted the btt port to allow for a tunnel to form within the leg but the co2 pressure in the leg would not increase and a tunnel would not form.Incision length was normal evh incision.No more than 1 inch long.Air was added to the balloon around the port, the co2 line was disconnected and reconnected, and the co2 insufflation device was checked.Co2 flow was at 5 and pressure was at 10.Measured co2 pressure was 0 and therefore flow remained at 5.None of this corrected the problem.Therefore, an accessory pack was opened up and a new btt port was used.This change allowed for the co2 pressure to be maintained which ultimately created a tunnel within the leg.There was a slight procedural delay when the harvester waited for the accessory pack to get a new btt port.No adverse outcomes or injuries occurred due to the defect.

Manufacturer Narrative

Trackwise # (b)(4).Updated section: b4, g4, g7, h2, h3, h6, h10 the device was returned to the factory for evaluation on 05/17/2022.An investigation was conducted on 06/01/2022.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.The lot history record review was completed.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 batch manufacturing process and the reported failure.

Event Description

Related to (b)(4).

• Brand Name: VASOVIEW HEMOPRO 2 (W/VASOSHIELD)
• 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: 14594130
• MDR Text Key: 293280865
• Report Number: 2242352-2022-00474
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700451
• UDI-Public: 00607567700451
• 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: Initial,Followup
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2024
• Device Model Number: VASOVIEW HEMOPRO 2 (W/VASOSHIELD)
• Device Catalogue Number: C-VH-4001
• Device Lot Number: 25163168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1