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

Model Number VH-4000

Device Problem Failure to Cut (2587)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/21/2024

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 vessel harvesting procedure, vasoview hemopro 2 would not seal the branches; "the energy would not seal." the jaws did not appear to have enough heat and only sometimes cut the tissue effectively.A new device was opened to complete the procedure.There was no procedural delay.The patient had minimal bleeding.

Event Description

N/a.

Manufacturer Narrative

Trackwise#: (b)(4).Updated sections: b4, d9, e1, g3, g6, h2, h3, h6, h10 the device was returned to the factory for evaluation on 03/18/2024.An investigation was conducted on 03/19/2024.A visual inspection was conducted.Both the harvesting device and cannula was returned for evaluation.Signs of clinical use and evidence of blood was observed on both devices.There were no visual defects observed on the intact cannula or the intact c-ring.There were no visual defects observed on the intact clear silicone insulation on both the cold and hot jaws.The hot jaw was observed to be bent slightly forward and not meeting with the cold jaw when the jaws were closed.The heater wire was observed to be flexed and bent away from the hot jaw from the base of 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.No excessive smoke and/or steam were observed during the testing.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 done due to the condition of the heater wire.Based on the results of the evaluation, the reported failure "failure to cut" was not confirmed, however, the analyzed failures "material twisted/bent wire" , "material twisted; bent jaw" and "mechanical problem- jaws unable to open/close" were observed.The lot # 3000359277 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.

• 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: 18889328
• MDR Text Key: 337540324
• Report Number: 2242352-2024-00239
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VH-4000
• Device Catalogue Number: VH-4000
• Device Lot Number: 3000359277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.