MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. FLUECY PLUS ENDOVASCULAR STENT GRAFT

Model Number	FEM12120
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Based on the investigation of the returned catheter sample a break and detachment of the distal delivery system tip could be confirmed.The delivery system was returned in used condition without stent graft and without distal tip so that it could be concluded that the tip broke upon deployment as reported.Further damage or deformation could not be found so that a further detailed fracture analysis could not be made.An indication for a process related issue could not be found.Based on the information available a definite root cause for the reported event could not be determined.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model fem12120 endovascular stent graft allegedly broke and detached.The tip of the inner catheter and guidewire were removed with a snare.There was no reported patient injury.This information was received from one source.The patient was a (b)(6) year-old female weighing (b)(6) pounds.

• Brand Name: FLUECY PLUS ENDOVASCULAR STENT GRAFT
• Common Device Name: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8795412
• Report Number: 2020394-2019-01533
• Device Sequence Number: 13963845
• Product Code: PFV
• UDI-Device Identifier: 04049519008677
• UDI-Public: (01)04049519008677
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/16/2019

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
• Operator of Device: No Information
• Device Model Number: FEM12120
• Device Catalogue Number: FEM12120
• Device Lot Number: ANDQ1744
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 07/16/2019
• Patient Sequence Number: 1