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

Model Number VH-3500

Device Problems Failure to Cut (2587); Environmental Particulates (2930)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/22/2023

Event Type  Injury  

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro vh-3500, they experienced a great deal of bleeding and had to convert to open vein harvest.There was quite a bit of smoke inside the tunnel with each use of the cautery.It seemed like the cautery was taking an excessive amount of time to seal branches.There was quite a bit of bleeding that, in at least one location, was from an incompletely sealed branch.No resistance was noted.The jaws were closed during insertion.The device was fully intact.They needed to make 2 additional incisions to control bleeding.The planned surgical procedure was not altered, they were able to complete the evh.The procedure was completed with an open technique.They were able to get the vein out with the device but used skip incisions to localize and control bleeding.No delay in the vein harvest, but significant time was required to control bleeding after the vein was harvested.1 unit of prbcs and a pack of ffp was used for blood transfusion.They had to place a drain and do skip incisions to locate the source of the bleeding.The patient was discharged with a leg drain.

Manufacturer Narrative

Tw 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.

Manufacturer Narrative

Trackwise # (b)(4).The device was returned to the factory for evaluation on 07/05/2023.An investigation was conducted on 07/13/2023.A visual inspection was conducted.Signs of clinical use and heavy amount of charred material was observed on the base of the jaws.There were no visual defects observed on the intact jaws or the heater wire.An electrical evaluation was conducted.A pre-cautery test was performed per the instruction for use (ifu) with a reference adapter, reference cable, and reference power supply vh-3010 at level 2.5.The device passed the pre-cautery test; it produced visible steam and heat during ten (10) 3-second activations and shut off when the toggle was released.To evaluate the safety shut down system, a polyfuse activation test was performed 5 times over 10 minutes.The device shut off after the period of sustained activation and reactivated after 10-second cooling period with no incident each time.No excessive smoking was observed during testing.The jaws were gently cleaned of debris and char with a saline and gauze pad as indicated in the direction for use (cv000006999).An activation and transection capability test was performed over four (4) repetitions using "max life test method (b)(4).The device did successfully transect tissue four (4) times.No excessive smoking was observed during testing.Based on the returned condition of the device, the investigation results, the reported failures, "failure to cut¿ and "environmental particulates were not confirmed.The lot # 3000296498 history record review was completed.There were 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

N/a.

• Brand Name: VASOVIEW HEMOPRO
• 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: 17325406
• MDR Text Key: 319106202
• Report Number: 2242352-2023-00588
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567701250
• UDI-Public: 00607567701250
• Combination Product (y/n): N
• PMA/PMN Number: K153194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2024
• Device Model Number: VH-3500
• Device Catalogue Number: VH-3500
• Device Lot Number: 3000296498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 97 KG