MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR, LLC FUSION BIOLINE 8MM-80CM SUPP PERIPHERAL; VASCULAR GRAFT

Model Number M00201503088B0

Device Problems Loose or Intermittent Connection (1371); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2014

Event Type  malfunction  

Event Description

The hospital reported that during an axillary-femoral repair, after tunneling graft through gore tunneler the rings came loose and started to unwrap.The graft was tunneled through the sheath.The physician took a piece of the graft that was cut off from the back table and pulled graft through his fingers.Afterwards, the rings were loose and could be taken off.The physician was unhappy with the rings and the ease in which they could be removed.Currently, the patient is in good condition.The graft was used to complete the procedure.

Manufacturer Narrative

Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.A lot history record review was completed for the reported product lot number.There was no non-conformance recorded in the lot history.(b)(4).

• Brand Name: FUSION BIOLINE 8MM-80CM 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 ; 9737097690
• MDR Report Key: 3847116
• MDR Text Key: 4657189
• Report Number: 2242352-2014-00301
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Model Number: M00201503088B0
• Device Lot Number: 25082933
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2014
• Initial Date FDA Received: 03/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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