MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR, LLC FUSION BIOLINE 8MM-60CM SUPP PERIPHERAL; VASCULAR GRAFT

Model Number M00201503068B0

Device Problem Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2014

Event Type  malfunction  

Event Description

The hosp reported that during a fem/fem bypass the supported rings on the fusion bioline 8mm-60cm supp peripheral came off at the pt's left side at the anastamosis.They rings were in-tact upon implantation and came off the graft during the anastamosis process.It appeared as it the adhesive bonding came off.The hosp reported no pt effects.

Manufacturer Narrative

Since the device is not available to be returned to us, a technical eval cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop/ there was no nonconformance recorded in the lot history which would be considered related to the reported event.(b)(4).

• Brand Name: FUSION BIOLINE 8MM-60CM SUPP PERIPHERAL
• Type of Device: VASCULAR GRAFT
• 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: 4253410
• MDR Text Key: 14879241
• Report Number: 2242352-2014-01232
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131778
• 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: 10/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: M00201503068B0
• Device Lot Number: 25090887
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• 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