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

Model Number FEM12120

Device Problems Break (1069); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 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
• Type of Device: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 8795412
• MDR Text Key: 151346593
• Report Number: 2020394-2019-01533
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008677
• UDI-Public: (01)04049519008677
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Device Model Number: FEM12120
• Device Catalogue Number: FEM12120
• Device Lot Number: ANDQ1744
• Initial Date Manufacturer Received: 06/30/2019
• Initial Date FDA Received: 07/16/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1