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

Model Number VH-4000

Device Problems Thermal Decomposition of Device (1071); Peeled/Delaminated (1454); Failure to Cut (2587); Environmental Particulates (2930)

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

Event Date 02/02/2024

Event Type  malfunction  

Manufacturer Narrative

Tw 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 was being used as normal and in the process of cutting branches a large amount of eschar built up on the jaws was noticed.The cutting tool was taken out to be cleaned, and the procedure resumed.When trying to cut branches, there were large amounts of smoke, more than normal.The jaws were smoking when not activated, and jaws were no longer working to cut branches.The jaws were taken out again and jaws melted, there was a smell similar to melted plastic, jaws turned brown/black, and broke off.No part fell into tunnel or patient.It appeared like the cutting filament was damaging or burning the parts of the jaw itself.A new device was used to complete the procedure without issue or further delay.No harm to patient.

Manufacturer Narrative

Trackwise #: (b)(4).The lot # 3000357804 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.The device was recieved in the lab on on 03/26/2024.Shipping information was not observed during intake to get delivery date.A visual inspection was conducted on 03/26/2024.Signs of clinical use and evidence of blood was observed.There were no visual defects observed on the intact clear silicone insulation on both the cold and hot jaws.The heater wire was observed to be bent and twisted away from the hot jaw with detachment at the tip of the hot jaw.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 only transected twice due to the condition of the heater wire.The jaws were gently cleaned of debris and char with a saline and gauze pad as indicated in the direction for use (cv000008979).A temperature and resistance test was conducted to evaluate the device function per hemopro 2 final test 90523436 rev w.The resistance value was measured at.65 ohms which is within specification.The device passed the temperature measurements test.The displayed temperature increased and turned green within the 2 second specified timeframe.The displayed temperature decreased once the toggle swivel was released.Based on the returned condition of the device as well as the evaluation results, the reported failure "failure to cut" was confirmed.The reported failures "thermal decompostion of device" as well as "environmental particulates" were not confirmed, however, the analyzed failure "material twisted/bent wire" was observed.

Manufacturer Narrative

Trackwise # (b)(4).Corrected section: h6 problem code 1454 changed to 2587.Device received, evaluation will be performed and a follow up mdr will be submitted when completed.

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: 18783960
• MDR Text Key: 336262369
• Report Number: 2242352-2024-00145
• Device Sequence Number: 1
• Product Code: GEI
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• 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: 3000357804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 147 KG