MAUDE Adverse Event Report: LAKE REGION MEDICAL 0.014" SHEPHERD GUIDEWIRE - STRAIGHT 300 CM - 6 GMS

Model Number	901068-14
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint underway and will be attached to this report.
Event or Problem Description
A shepherd.014 guide wire was advanced in a chronic total occlusion (cto) in the mid posterior tibial (pt) artery.The user used force to advance the guide wire when it perforated the pt.An unsuccessful attempt to advance through the cto was then made using a non-csi guide wire.No intervention was performed and the patient's condition was good.
Event or Problem Description
A shepherd.014 guide wire was advanced in a chronic total occlusion (cto) in the mid posterior tibial (pt) artery.The user used force to advance the guide wire when it perforated the pt.An unsuccessful attempt to advance through the cto was then made using a non-csi guide wire.No intervention was performed and the patient's condition was good.

• Brand Name: 0.014" SHEPHERD GUIDEWIRE - STRAIGHT 300 CM - 6 GMS
• Common Device Name: 0.014" SHEPHERD GUIDEWIRE - STRAIGHT 300 CM - 6 GMS
• Manufacturer (Section D): LAKE REGION MEDICAL; parkmore west business park; galway, H91 C K22; EI H91 CK22
• Manufacturer (Section G): LAKE REGION MEDICAL; 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: 15666245
• Report Number: 3006010712-2022-00047
• Device Sequence Number: 14134298
• Product Code: DQX
• UDI-Device Identifier: 30850026568586
• UDI-Public: 10850026568582
• 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
• Report Date (Section B): 12/05/2022

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: 04/30/2025
• Device Model Number: 901068-14
• Device Catalogue Number: 7-10096-06
• Device Lot Number: 7175968
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2022
• Supplement Date Received by Manufacturer: 10/17/2022
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2022
• 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