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

Model Number VASOVIEWHEMPRO VH-3500

Device Problems Leak/Splash (1354); Failure to Cut (2587)

Patient Problem Blood Loss (2597)

Event Date 03/20/2020

Event Type  Injury  

Manufacturer Narrative

Trackwise id # (b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro vh-3500.Pa-c stated that during a procedure today they had bleeding on the branches that did not seal properly, small branches oozed.Did not experience this with the vasoview hemopro vh- 3000,at the same setting.The customer did not save the device, nor did they open a new device.Just a comment/complaint on their experience.No patient injury.

Manufacturer Narrative

Trackwise id (b)(4).Updated sections: g4, g7, h2, h3, h6, h10.Corrected sections: h6: device codes: "leak" code removed, a lot history record review was completed for lots 25149653, 25149635, 25149281; the last (b)(4) lots shipped to the account prior to the event date.There were no ncmr's reported for lot# 25149653 and lot# 25149635.There was one ncmr reported for lot#25149281, which is not related to the reported event.H3 other text : device discarded.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro vh-3500.Pa-c stated that during a procedure today they had bleeding on the branches that did not seal properly, small branches oozed.Did not experience this with the vasoview hemopro vh- 3000, at the same setting.The customer did not save the device, nor did they open a new device.Just a comment/complaint on their experience.No patient injury.

• Brand Name: VASOVIEW HEMOPRO
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 9951617
• MDR Text Key: 187550055
• Report Number: 2242352-2020-00369
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K153194
• 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: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VASOVIEWHEMPRO VH-3500
• Device Catalogue Number: VH-3500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 03/20/2020
• Initial Date FDA Received: 04/11/2020
• Supplement Dates Manufacturer Received: 04/29/2020
• Supplement Dates FDA Received: 04/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention