MAUDE Adverse Event Report: LAKE REGION MEDICAL 0.014" SHEPHERD ES GUIDEWIRE - STRAIGHT 300 CM - 4 GMS

Model Number	901068-02
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint investigation underway and will be attached to this report.
Event or Problem Description
A shepherd guide wire was being used to access the anterior tibial artery through a pedal retrograde approach to advance past a chronic total occlusion (cto) when the tip of the shepherd wire was dislodged and fractured in the cto.The fractured tip was stuck in the adventitia layer of the artery.An additional surgery was performed to snare the broken tip of the wire.The patient was in stable condition and had good flow of the treated vessel.
Additional Manufacturer Narrative
Complaint investigation underway and will be attached to this report.
Event or Problem Description
A shepherd guide wire was being used to access the anterior tibial artery through a pedal retrograde approach to advance past a chronic total occlusion (cto) when the tip of the shepherd wire was dislodged and fractured in the cto.The fractured tip was stuck in the adventitia layer of the artery.An additional surgery was performed to snare the broken tip of the wire.The patient was in stable condition and had good flow of the treated vessel.
Additional Manufacturer Narrative
Complaint investigation underway and will be attached to this report.
Event or Problem Description
A shepherd guide wire was being used to access the anterior tibial artery through a pedal retrograde approach to advance past a chronic total occlusion (cto) when the tip of the shepherd wire was dislodged and fractured in the cto.The fractured tip was stuck in the adventitia layer of the artery.An additional surgery was performed to snare the broken tip of the wire.The patient was in stable condition and had good flow of the treated vessel.

• Brand Name: 0.014" SHEPHERD ES GUIDEWIRE - STRAIGHT 300 CM - 4 GMS
• Common Device Name: 0.014" SHEPHERD ES GUIDEWIRE - STRAIGHT 300 CM - 4 GMS
• Manufacturer (Section D): LAKE REGION MEDICAL; parkmore west business park; galway, H91CK 22; EI H91CK22
• Manufacturer (Section G): LAKE REGION MEDICAL; parkmore west business park; galway, H91CK 22; EI H91CK22
• Manufacturer Contact: krishna priya kodumadu venkittaraman ; parkmore west business park; galway, H91CK-22 ; EI H91CK22
• MDR Report Key: 16022124
• Report Number: 3006010712-2022-00056
• Device Sequence Number: 5858737
• Product Code: DQX
• UDI-Device Identifier: 10850026568544
• UDI-Public: 10850026568544
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 03/01/2023

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: 05/31/2025
• Device Model Number: 901068-02
• Device Catalogue Number: 7-10096-02
• Device Lot Number: 7211881
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2022
• Supplement Date Received by Manufacturer: 12/09/2022; 12/09/2022
• Initial Report FDA Received Date: 12/21/2022
• Supplement Report FDA Received Date: 01/25/2023; 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2022
• 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 Age: 78 YR
• Patient Sex: Male
• Patient Weight: 63 KG