MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYS; ELECTROSURGICAL, CUTTING & COAGULATION AND ACCESSORIES

Model Number VH-3000

Device Problems Crack (1135); Peeled/Delaminated (1454)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

During endoscopic harvesting of the right greater saphenous vein for right lower extremity calcification with severe peripheral arterial disease.The tip of the jaw of the vascular vessel harvesting system started to crack and peel while being used in the pt.Device was removed before any artifact fell off into the pt.Fda safety report id# (b)(4).

• Brand Name: VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYS
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION AND ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; wayne NJ 07470
• MDR Report Key: 8491604
• MDR Text Key: 141238561
• Report Number: MW5085630
• Device Sequence Number: 0
• Product Code: GEI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VH-3000
• Device Catalogue Number: VH-3000
• Device Lot Number: 25144212
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/05/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 92