MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR, LLC VASO VIEW HEMOPRO; ENDOSCOPIC VESSEL HARVESTING

Model Number VH-3000

Device Problem Image Resolution Poor (1306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2015

Event Type  malfunction  

Event Description

The hosp reported that during an endoscopic vein harvesting procedure, the clear conical tip of the vasoview hemopro 1 had some markings on it that was partially obstructing the view of the harvester.A replacement device was used to complete the procedure.The hosp did not report any pt effects.

Manufacturer Narrative

The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the eval is completed.A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.There are no other similar complaints reported against this batch.(b)(4).

• Brand Name: VASO VIEW HEMOPRO
• Type of Device: ENDOSCOPIC VESSEL HARVESTING
• 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: 4502706
• MDR Text Key: 21540116
• Report Number: 2242352-2015-00021
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2015
• Device Model Number: VH-3000
• Device Lot Number: 25107890
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/26/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2014
• 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
• Patient Age: 78 YR
• Patient Weight: 85