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

Model Number VASOVIEW HEMOPRO 2

Device Problem Material Twisted/Bent (2981)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 12/17/2020

Event Type  malfunction  

Manufacturer Narrative

Trackwise id # (b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro 2,they have asked the theatre circulating staff nurse to open the vasoview hemopro 2 kit, as they have opened the sterile plastic tray, they have noticed that the bipolar forcep tip is damaged, metal wires was exposed.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Trackwise # (b)(4).The device was not returned to maquet cardiac surgery for investigation, however a photograph was provided by the account.A photographic inspection was conducted on 01/19/2021.Signs of clinical use and no evidence of blood was observed in the photograph.The heater wire was observed to be flexed away from the hot jaw with detachment at the tip of the hot jaw.The clear silicone insulation on both the cold and hot jaws was observed to be intact.No visual defects were observed.Based on the returned condition of the device, the reported failure "material twisted/ bent wire" was confirmed.The lot # 25153007 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 preparation for a coronary artery bypass procedure,using vasoview hemopro 2,they have asked the theatre circulating staff nurse to open the vasoview hemopro 2 kit, as they have opened the sterile plastic tray, they have noticed that the bipolar forcep tip is damaged, metal wires was exposed.A replacement device was used to complete the procedure.No patient involvement.

Manufacturer Narrative

Trackwise # (b)(4).Updated section: d10, g4, g7, h2, h3, h6, h10, h11.Corrected section : h6- corrected to "not patient involvement" the device was returned to the factory on (b)(6) 2021.An investigation was conducted on (b)(6) 2021.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.The heater wire was observed to be completely flexed and twisted away from the hot jaw with detachment at the tip.No electrical testing was conducted due to the damage of the heater wire.No other visual defects were observed.Based on the returned condition of the device, the reported failure "material twisted/ bent wire" was confirmed.The lot # 25153007 1history 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 preparation for a coronary artery bypass procedure,using vasoview hemopro 2,they have asked the theatre circulating staff nurse to open the vasoview hemopro 2 kit, as they have opened the sterile plastic tray, they have noticed that the bipolar forcep tip is damaged, metal wires was exposed.A replacement device was used to complete the procedure.No patient involvement.

• Brand Name: VASOVIEW HEMOPRO 2
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 11159235
• MDR Text Key: 226569743
• Report Number: 2242352-2021-00048
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2021

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: 08/14/2022
• Device Model Number: VASOVIEW HEMOPRO 2
• Device Catalogue Number: C-VH-4000
• Device Lot Number: 25153007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 01/20/2021; 01/19/2021
• Supplement Dates FDA Received: 01/20/2021; 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1