MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR, LLC VASOVIEW HEMOPRO 2

Model Number VH-4000

Device Problem Image Resolution Poor (1306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure, after opening the package, it was observed that the dissection tip on the vasoview hemopro 2 was scratched.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Since the device in 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.A lot history record review was completed for lots 25109968, 25109979 and 25110159, which were shipped to the account prior to the aware date.There was no nonconformance recorded related to the complaint defect.Internal complaint number - (b)(4).

• Brand Name: VASOVIEW HEMOPRO 2
• Manufacturer (Section D): MAQUET CARDIOVASCULAR, LLC; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR, LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: tina evancho ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4648785
• MDR Text Key: 5597729
• Report Number: 2242352-2015-00229
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VH-4000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1