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

Model Number VH-4000

Device Problems Environmental Particulates (2930); Material Twisted/Bent (2981)

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

Event Date 12/08/2023

Event Type  malfunction  

Manufacturer Narrative

Trackwise id (b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 they noted a lot of smoke during the cautery phase of the harvest.Was able to finish the harvest and no bleeding was noted.Once they took device out of the tunnel they noticed that the wire had come apart from the jaw.Vein was prepared with no issues/no bleeding in the tunnel.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 they noted a lot of smoke during the cautery phase of the harvest.The tool was used on fatty tissue.Was able to finish the harvest and no bleeding was noted.Once they took device out of the tunnel they noticed that the wire had come apart from the jaw.There was not a procedural delay.Vein was prepared with no issues/no bleeding in the tunnel.

Manufacturer Narrative

Trackwise#: (b)(4).

Manufacturer Narrative

Tw # (b)(4).The device was returned to the factory for evaluation on 01/03/2024.An investigation was conducted on (b)(6) 2024.A visual inspection was conducted.The harvesting device was returned inside the cannula.Signs of clinical use and evidence of blood was observed on the cannula.A mechanical evaluation was conducted.The harvesting device was removed from the cannula with no physical or visual difficulties observed.There were no visual defects observed on the intact cannula or c-ring.Signs of clinical use and evidence of charred material was observed on the heater wire.The heater wire was observed to be flexed away from the hot jaw from the base of the hot jaw with detachment at the tip of the hot jaw.The clear silicone insulation on the tips of the hot and cold jaw were observed to be peeled back, exposing the metal tips of both the jaws with no detachment observed.No other visual defects were observed.An electrical evaluation was conducted.A pre-cautery test was performed per the direction for use (dfu) with a reference cable, adapter, and reference power supply vh-3010 at level 3.0.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.An activation and transection capability test was performed over four (4) repetitions using "max life test method stm2048073 rev aa.The device successfully transected tissue four (4) times.No final testing was conducted due to the condition of the heater wire and the jaws.Based on the returned condition of the device as well as the evaluation results, the reported failure "material twisted/bent wire" was confirmed.The reported failure "environmental particulates-smoke" was not confirmed.The analyzed failure "peeled; delaminated; jaw" was observed.The lot # 3000350116 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

N/a.

• 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: 18382697
• MDR Text Key: 331192085
• Report Number: 2242352-2023-01065
• 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: Physician Assistant
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VH-4000
• Device Catalogue Number: VH-4000
• Device Lot Number: 3000350116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 96 KG