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

Model Number	VH-3000
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
An elderly male patient with 2 week history of chest pain was scheduled to undergo a coronary artery bypass graft.While harvesting the greater saphenous vein, the plastic part of the bovie tip of the vasoview hemopro broke off inside the patient's right leg.A new vasoview hemopro kit was opened and used to successfully retrieve the plastic parts inside the patient's leg.Please refer to two previous reported incidents with broken and cracked tip- same product.

• Brand Name: VASOVIEW HEMOPRO
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 9172728
• Report Number: 9172728
• Device Sequence Number: 2323844
• Product Code: GEI
• UDI-Device Identifier: 00607567700345
• UDI-Public: (01)00607567700345(17)200724(10)25147427
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/18/2019
• Report Date (Section F): 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VH-3000
• Device Catalogue Number: VH-3000
• Device Lot Number: 25147427
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/09/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 114
• Date Report Sent to FDA: 09/18/2019