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

Model Number VASOVIEWHEMPRO VH-3500

Device Problems Particulates (1451); Environmental Particulates (2930)

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

Event Date 06/02/2022

Event Type  Injury  

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.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure vasoviewhempro vh-3500, there was a small curled piece of white plastic in the tunnel while using the hemopro device.They noticed it and was able to retrieve it with the hemopro jaws and completed the procedure without incident.No additional incisions were needed for this issue.No procedural delay.Removing the plastic piece took less than 30 seconds.There was no patient injury.They could not determine the origin of the piece.

Manufacturer Narrative

Trackwise#: (b)(4).Updated sections: b4, g4, g7, h2, h3, h6, h10, h11 corrected sections: h6--changed problem code to 1451 the device was returned to the factory for evaluation on (b)(6)2022.An investigation was conducted on (b)(6)2022.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed on the harvesting device handle as well as on the cannula.The harvesting device was observed to be intact, with no visual defects observed.The cannula was observed to be intact, with no visual defects observed.The harvesting device was returned inside the cannula.A mechanical evaluation was conducted.The harvesting device was removed from the cannula with no physical or visual difficulties.A reference endoscope was inserted into the cannula until it snapped into place with no physical or visual difficulties.The harvesting device was inserted into the cannula with no physical or visual difficulties.A white piece of material was observed.An engineer evaluation was conducted on (b)(6)2022.Photographs were taken of the inner lumen, and it was observed that there were nicks and scratches on the lumen.No other visual defects were observed.Based on the returned condition of the device, the reported failure "particulates; shavings¿ was confirmed.The lot #3000234005 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: 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: 14773124
• MDR Text Key: 294493096
• Report Number: 2242352-2022-00563
• 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: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2023
• Device Model Number: VASOVIEWHEMPRO VH-3500
• Device Catalogue Number: VH-3500
• Device Lot Number: 3000234005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 85 KG