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	12/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
An elderly male patient with history of chronic obstructive pulmonary disease (copd), hypertension (htn), and peripheral vascular disease (pvd) presents with non-st-elevation myocardial infarction (stemi).He went to operating room for coronary artery bypass grafting (cabg) x 3, maze and atrial appendage clip.During the harvest of vessel in the right leg, "a part of the rubber tip of the hemopro broke off while inside of the patient's right leg.Caregiver was able to remove the broken piece intact from the patient's leg without an extra incision.".

• 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: 9505190
• Report Number: 9505190
• Device Sequence Number: 19318359
• Product Code: GEI
• UDI-Device Identifier: 00607567700345
• UDI-Public: (01)00607567700345(17)200925(10)25148209
• 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): 12/11/2019
• Report Date (Section F): 12/11/2019

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
• Operator of Device: Health Professional
• Device Model Number: VH-3000
• Device Catalogue Number: VH-3000
• Device Lot Number: 25148209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/20/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 74
• Date Report Sent to FDA: 12/11/2019