MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEWHEMPRO VH-3500; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VASOVIEWHEMPRO VH-3500

Device Problems Crack (1135); Peeled/Delaminated (1454)

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

Event Date 05/23/2022

Event Type  malfunction  

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro vh-3500 had a cracked tip.No parts fell into patient.No procedural delay.Case completed with another hemopro.No harm to patient.

Manufacturer Narrative

Trackwise id (b)(4).

Manufacturer Narrative

Trackwise#: (b)(4).The lot # 3000234362 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 returned to the factory for evaluation on 06/16/2022.An investigation was conducted on 07/20/2022.A visual inspection was conducted.Signs of clinical use and evidence of charred material was observed on the heater wire.The heater wire was observed to be intact, with no visual defects observed.The gray silicone insulation on the tip of the cold jaw was observed to be peeled back from the tip, with no detachment of silicone observed.Based on the returned condition of the device, the reported failure "peeled;jaw" was confirmed.

Event Description

N/a.

Manufacturer Narrative

The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.Trackwise id#: (b)(4).

Manufacturer Narrative

Tw# (b)(4).Corrected section- h6 problem code changed to 1454.

• Brand Name: VASOVIEWHEMPRO VH-3500
• 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: 14760504
• MDR Text Key: 302925356
• Report Number: 2242352-2022-00558
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2023
• Device Model Number: VASOVIEWHEMPRO VH-3500
• Device Catalogue Number: C-VH-3500
• Device Lot Number: 3000234362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1