MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR, LLC FUSION BIOLINE 8MM-40CM SUPP PERIPHERAL; VASCULAR GRAFT

Model Number VS01503048B0

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Seroma (2069)

Event Type  Injury  

Event Description

The hospital reported that they explanted a fusion bioline 8mm-40cm supp peripheral which was used for a fem-pop bypass.The physician saw infection and seroma.Fusion bioline graft was taken out to clear up the infection and seroma.The surgeon would not comment on the condition of the patient.

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.There was no non-conformance recorded in the lot history which would be considered related to the reported event.There are no other similar complaints reported against this batch.(b)(4).

• Brand Name: FUSION BIOLINE 8MM-40CM 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: 4155329
• MDR Text Key: 4930829
• Report Number: 2242352-2014-01054
• 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: Physician
• Type of Report: Initial
• Report Date: 09/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: VS01503048B0
• Device Catalogue Number: M00201503048B0
• Device Lot Number: 25091254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2014
• Initial Date FDA Received: 10/07/2014
• 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
• Patient Outcome(s): Other