MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR, LLC VASOVIEW 6 ACCESSORY PACK; ENDOSCOPIC VESSEL HARVESTING

Model Number VH-2004

Device Problem Image Resolution Poor (1306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/17/2015

Event Type  malfunction  

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, first a regular vh-3200 was opened.When the harvester found tip altered the focus of the camera, she opened an accessory kit (vh-2004).That tip was found to be cloudy as well so a second accessory pack was opened.At that point, the sale representative was called into the case from the other room and had her insert a tip into the leg to see if that would make a difference.She could focus easier at that point and proceeded with the case.A replacement device was used to complete the procedure.The hospital did not report any patient effects.Refer to manufacture report number 2242352-2015-00278 and 2242352-2015-00292 for the other two related events.

Manufacturer Narrative

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

• Brand Name: VASOVIEW 6 ACCESSORY PACK
• 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: 4693110
• MDR Text Key: 22150991
• Report Number: 2242352-2015-00293
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041981
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 03/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2015
• Device Model Number: VH-2004
• Device Lot Number: 25100293
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/02/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2014
• 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: 73 YR