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

Model Number VH-3500

Device Problem Mechanical Problem (1384)

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

Event Date 09/27/2023

Event Type  malfunction  

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro vh-3500 c-ring would not completely retract back into the cannula.They tried it several times and then used a new kit to finish the case.There was a slight procedural delay while they tried to troubleshoot.No patient harm was reported.

Manufacturer Narrative

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

Manufacturer Narrative

Trackwise # (b)(4).Updated section: b4, g4, g7, h2, h3, h6, h10.The device was returned to the factory for evaluation on 10/16/2023.An investigation was conducted on 10/17/2023.An visual inspection was conducted.Signs of clinical use and evidence of blood were observed on the device.The harvesting device was returned inside the cannula.The c-ring was observed to be intact with no visual defects.A large piece of tissue was observed in the curve of the c-ring.The heater wire and gray silicone insulation of the jaws were observed to be intact with no visual defects.A severe kink was observed in the black shaft of the harvesting device.A mechanical evaluation was conducted.The c-ring slider was manipulated to retract the c-ring into the cannula with no physical difficulties.The blue toggle of the harvesting device was manipulated to open and close the jaws, however the jaws did not fully open due to the kinked state of the shaft.Based on the returned condition of the device and evaluation results, the reported failure "mechanical problem; c-ring" was not confirmed, however the analyzed failures "material twisted/bent; shaft" and ""mechanical problem; jaws" were confirmed.The lot # 3000335670 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
• 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: 17965505
• MDR Text Key: 326046098
• Report Number: 2242352-2023-00872
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VH-3500
• Device Catalogue Number: VH-3500
• Device Lot Number: 3000335670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 61 KG