MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR, LLC VASOVIEW HEMOPRO 2 WITH VASOSHIELD; ENDOSCOPIC VESSEL HARVESTING

Model Number VH-4001

Device Problem Inflation Problem (1310)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

The hospital reported that the balloon did not inflate on the short port btt on the vasoview hemopro 2 with vasoshield.It is unk if the device is returning.

Manufacturer Narrative

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.A lot history record review was completed for lots 25105361, 25105637 and 25106115 the last 3 lots shipped to the account prior to the aware date.There were no nonconformances related to the subject code defect.(b)(4).

• Brand Name: VASOVIEW HEMOPRO 2 WITH VASOSHIELD
• 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: 4347570
• MDR Text Key: 5143242
• Report Number: 2242352-2014-01316
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VH-4001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2014
• 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