MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW 7 XB BISECTOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VASOVIEW 7 XB BISECTOR (US)

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Discomfort (2330)

Event Date 09/23/2019

Event Type  Injury  

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.Device was discarded.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure using vasoview 7 xb bisector.The right superficial femoral artery was harvested instead of the greater saphenous vein.There were no immediate complications from the procedure.Nursing alerted the medical staff that the patient had developed a cool lower extremity with discoloration and absent pulses to the right lower extremity.The patient underwent subsequent surgeries which included embolectomy, right femoral popliteal bypass and fasciotomies of the right lower leg.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure using vasoview 7 xb bisector.The right superficial femoral artery was harvested instead of the greater saphenous vein.There were no immediate complications from the procedure.Nursing alerted the medical staff that the patient had developed a cool lower extremity with discoloration and absent pulses to the right lower extremity.The patient underwent subsequent surgeries which included embolectomy, right femoral popliteal bypass and fasciotomies of the right lower leg.

Manufacturer Narrative

Updated sections: g4,g7,h2,h3,h6,h10 h1 correction: changed to serious injury internal complaint number: (b)(4).A lot history record review was completed for lots 25147065, 25147129, 25146969; the last 3 lots shipped to the account prior to the event date.There were no ncmr's recorded in the lot history for lot#25147129 and lot#25146969.There was one ncmr reported for lot#25147065, however it is unrelated to the reported event.H3 other text : the device was discarded.

• Brand Name: VASOVIEW 7 XB BISECTOR
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 9210911
• MDR Text Key: 186152064
• Report Number: 2242352-2019-01164
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K041981
• 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: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VASOVIEW 7 XB BISECTOR (US)
• Device Catalogue Number: VH-3200
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR