MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR, LLC COOLEY GRAFT; VASCULAR GRAFTS

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

Physician asked for information on the life span of a graft as there was a failure (weeping or something) of an implant that had been implanted about twenty years ago.The product manager is not sure if it is a cooley graft or a competitor graft.The physician is checking on what graft was implanted.

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.(b)(4).

• Brand Name: COOLEY GRAFT
• Type of Device: VASCULAR GRAFTS
• 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: 4360176
• MDR Text Key: 19611658
• Report Number: 2242352-2014-01401
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Type of Report: Initial
• Report Date: 11/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2014
• 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
• Patient Outcome(s): Other