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

Model Number VASOVIEWHEMPRO VH-3500

Device Problem Fitting Problem (2183)

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

Event Date 09/20/2022

Event Type  malfunction  

Manufacturer Narrative

Trackwise id (b)(6).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 radial harvest procedure, vasoview hemopro vh-3500 distal end of the harvesting device seems to be getting caught up in the distal end of the harvesting cannula.Harvester thinks glued areas of the harvesting device are sticking out a bit and catching on end of harvesting cannula.A replacement device was used to complete the procedure.Second device had no such issues and case was completed smoothly.Did result in a delay due to having to switch out product.Product was switched out to prevent injury to the patient.

Event Description

N/a.

Manufacturer Narrative

Trackwise # (b)(4).Updated section: b4, g4, g7, h2, h3, h6, h10.The device was returned to the factory for evaluation on 09/26/2022.An investigation was conducted on 10/17/2022.A visual inspection was conducted.Signs of clinical use and evidence of blood and charred material was observed on the hater wire and the jaws.There were no visual defects observed on the jaws or the heater wire.The c-ring was observed to be intact, with no visual defects observed.The harvesting device was returned partially inserted into the cannula.There were no visual defects observed on the cannula.A mechanical evaluation was conducted.The harvesting device was removed from the cannula with no physical or visual difficulties observed.A reference endoscope was inserted into the cannula until it snapped into place with no visual or physical difficulties observed.The harvesting device was then inserted into the cannula with no physical or visual difficulties observed.Based on the returned condition of the device as well as the evaluation results, the reported failure "fitting problem-tool" was not confirmed.The lot 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: 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: 15591553
• MDR Text Key: 305603343
• Report Number: 2242352-2022-00851
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567701250
• UDI-Public: 00607567701250
• 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: 10/19/2022

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 Expiration Date: 05/21/2023
• Device Model Number: VASOVIEWHEMPRO VH-3500
• Device Catalogue Number: VH-3500
• Device Lot Number: 3000243753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2022
• Initial Date FDA Received: 10/12/2022
• Supplement Dates Manufacturer Received: 10/19/2022
• Supplement Dates FDA Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK.; UNKNOWN.