MAUDE Adverse Event Report: ABBOTT VASCULAR EMBOSHIELD NAV6 BAREWIRE WORKHORSE FILTER DELIVERY WIRE; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

Lot Number	4030461
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During a lower extremity angiogram/angioplasty, the emboshield nav6 radiopaque wire tip became lodged in the vessel.Wire tip became detached and was sitting in the distal tibial artery.Multiple attempts were made to snare and retrieve the wire tip unsuccessfully.Wire tip was unintentionally retained.

• Brand Name: EMBOSHIELD NAV6 BAREWIRE WORKHORSE FILTER DELIVERY WIRE
• Common Device Name: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 19839672
• Report Number: MW5157638
• Device Sequence Number: 6888459
• Product Code: NTE
• UDI-Device Identifier: 08717648137808
• UDI-Public: (01)08717648137808
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/23/2024

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: Health Professional
• Device Lot Number: 4030461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White