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

Model Number VASOVIEWHEMPRO VH-3500

Device Problem Intermittent Continuity (1121)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2020

Event Type  malfunction  

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 using vasoview hemopro vh-3500, the toggle switch on the hemopro was functioning sporadically (cutting and cauterization were intermittent).They were able to complete the vein harvest with the same device.The hospital did not report any patient effects.

Manufacturer Narrative

Trackwise # (b)(4).The device was returned to the factory on 12/09/2020.An investigation was conducted on 1/13/2020.A visual inspection was conducted.Signs of clinical use and heavy amounts of blood was observed on the harvesting device and the cannula.The cannula was observed to be intact, no visual defects were observed.There was heavy amounts of charred tissue and blood observed on the heater wire of the harvesting device.There were no visual defects observed on the silicone insulation.An electrical testing was conducted.A pre-cautery test was performed per the instruction for use (ifu cv000006799) with a reference cable and reference power supply vh-3010 at level 2.5.The device passed the pre-cautery test; it produced visible steam and audible sound during several activations over a period of 10 minutes and shut off when the toggle was released toggle.The pre-cautery test was repeated 10 times with no observed failure.An activation and transection capability test was performed over five (5) repetitions using the max life test method stm2048073 rev aa.The device activated and transected tissue five (5) times with no cautery failure observed.Based on the returned condition of the device, the reported failure "intermittent continuity" was not confirmed.The lot # 25153858 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

The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro vh-3500, the toggle switch on the hemopro was functioning sporadically (cutting and cauterization were intermittent).They were able to complete the vein harvest with the same device.The hospital did not report any patient effects.

• Brand Name: VASOVIEWHEMPRO VH-3500
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 11031649
• MDR Text Key: 222767583
• Report Number: 2242352-2020-01134
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2021
• Device Model Number: VASOVIEWHEMPRO VH-3500
• Device Catalogue Number: VH-3500
• Device Lot Number: 25153858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 47