MAUDE Adverse Event Report: MAQUET CV VASOVIEW HEMOPRO 2; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number C-VH-4000

Device Problems Inflation Problem (1310); Leak/Splash (1354)

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

Event Date 03/28/2016

Event Type  malfunction  

Manufacturer Narrative

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.(b)(4).

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 one way valve was faulty or leaking.The balloon on the btt would not hold air.A replacement device was used to complete the procedure.The hospital did not report any patient effects.The product is not returning.I was informed late afternoon by one of my pa's (b)(6).The case was with dr.(b)(6).She said the balloon on the blunt tip trocar would not hold air while she was doing the procedure.Apparently the 1 way valve was faulty or leaking.There were no patient affects and she was able to complete the case with no issues.I have no lot number information and the product will not be returning.

Manufacturer Narrative

A lot history record review was completed for lots 25122851, 25123213 and 25123341 the last 3 lots shipped to the account prior to the event date.There was no nonconformance recorded in the lot history.(b)(4).

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 one way valve was faulty or leaking.The balloon on the btt would not hold air.A replacement device was used to complete the procedure.The hospital did not report any patient effects.The product is not returning.I was informed late afternoon by one of my pa's (b)(6).The case was with dr.(b)(6).She said the balloon on the blunt tip trocar would not hold air while she was doing the procedure.Apparently the 1 way valve was faulty or leaking.There were no patient affects and she was able to complete the case with no issues.I have no lot# number information and the product will not be returning.

• Brand Name: VASOVIEW HEMOPRO 2
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 5598460
• MDR Text Key: 44157580
• Report Number: 2242352-2016-00380
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-VH-4000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Date Manufacturer Received: 07/05/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1