MAUDE Adverse Event Report: BRIVANT LIMITED 0.018" SHEPHERD GUIDEWIRE - STRAIGHT 300 CM - 6 GMS

Model Number	901068-16
Medical Device Problem Codes	Fracture (1260); Failure to Advance (2524)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	07/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint investigation underway and will be attached to this report.
Event or Problem Description
The physician advanced the shepherd guide wire through the superficial femoral artery (sfa) with in-stent restenosis near the distal sfa.The guide wire advanced behind the stent strut.The guide wire began to buckle when the physician became aware it was behind the stent strut.The guide wire was advanced proximally when the tip fractured.The tip fragment was entrapped by the stent and remains in vivo.Shepherd guide wire tip fractured and remains entrapped in vivo between the stent and vessel.
Additional Manufacturer Narrative
Complaint investigation underway and will be attached to this report.
Event or Problem Description
The physician advanced the shepherd guide wire through the superficial femoral artery (sfa) with in-stent restenosis near the distal sfa.The guide wire advanced behind the stent strut.The guide wire began to buckle when the physician became aware it was behind the stent strut.The guide wire was advanced proximally when the tip fractured.The tip fragment was entrapped by the stent and remains in vivo.Shepherd guide wire tip fractured and remains entrapped in vivo between the stent and vessel.

• Brand Name: 0.018" SHEPHERD GUIDEWIRE - STRAIGHT 300 CM - 6 GMS
• Common Device Name: 0.018" SHEPHERD GUIDEWIRE - STRAIGHT 300 CM - 6 GMS
• Manufacturer (Section D): BRIVANT LIMITED; parkmore west business park; galway, H91 C K22; EI H91 CK22
• Manufacturer (Section G): BRIVANT LIMITED; parkmore west business park; galway, H91 C K22; EI H91 CK22
• Manufacturer Contact: jaseem saqib ; parkmore west business park; galway, H91 C-K22 ; EI H91 CK22
• MDR Report Key: 15155349
• Report Number: 3006010712-2022-00030
• Device Sequence Number: 5320955
• Product Code: DQX
• UDI-Device Identifier: 10850026568681
• UDI-Public: 10850026568681
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2022

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 Expiration Date: 03/31/2025
• Device Model Number: 901068-16
• Device Catalogue Number: 7-10096-08
• Device Lot Number: 7174587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2022
• Supplement Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown