MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. GRAFT FLEX SM BEAD STD 7X800MM - LOG1965364; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number DF8007SC

Device Problem Material Rupture (1546)

Patient Problems Pain (1994); Pseudoaneurysm (2605)

Event Date 03/18/2020

Event Type  Injury  

Event Description

Pt had femoral tibial graft placed (b)(6) 2020.Pt had onset of groin pain.She came to er (b)(6) 2020 and was diagnosed with pseudoaneurysm due to ruptured graft.She had surgery today to repair the area.Fda safety report id# (b)(4).

• Brand Name: GRAFT FLEX SM BEAD STD 7X800MM - LOG1965364
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC. ; tempe AZ 85281
• MDR Report Key: 9897151
• MDR Text Key: 185682726
• Report Number: MW5093956
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DF8007SC
• Device Catalogue Number: DF8007SC
• Device Lot Number: VTDT0373
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 110