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

Model Number VH-4000

Device Problems Peeled/Delaminated (1454); Material Twisted/Bent (2981)

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

Event Date 11/02/2023

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 the saphenous vein was being harvested when the cauterizing contact electrode had separated from the jaw of the instrument.Piece did not appear to break off while inside the patient's leg.Harvest was finished without any adverse outcome to the patient.

Manufacturer Narrative

Trackwise#: (b)(4).H6--medical device ¿ problem code corrected from "1454" to "2981".

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 the saphenous vein was being harvested when the cauterizing contact electrode had separated from the jaw of the instrument.The heater wire was disconnected at one end.Piece did not appear to break off while inside the patient's leg.The procedure was completed using the same device.The process was 90-95% complete when the defect was discovered.There was no procedure delay.Harvest was finished without any adverse outcome to the patient.

Manufacturer Narrative

Trackwise#: (b)(4).The lot # 3000343889 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: 18380861
• MDR Text Key: 331183696
• Report Number: 2242352-2023-01056
• 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,Followup
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 3000343889
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 01/18/2024; 02/19/2024
• Supplement Dates FDA Received: 02/09/2024; 02/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/27/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 78 KG