MAUDE Adverse Event Report: LAKE REGION MEDICAL 0.018" SHEPHERD 30 GUIDEWIRE - STRAIGHT 300 CM - 30 GMS

Model Number	901068-12
Medical Device Problem Codes	Break (1069); Fracture (1260); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A shepherd.018 30g wire was used in an attempt to cross the proximal end of a complete total occlusion (cto) in the right superficial femoral artery.After multiple attempts to cross the cto with the wire, the wire broke during retraction, just proximal to the proximal 3cm tip.The fractured segment became stuck in a calcified branch or dissection plane.The fractured segment was unable to be removed and no snare was available.The procedure was aborted, and the patient was discharged after post procedure routine care.The patient was in stable condition.
Additional Manufacturer Narrative
Complaint investigation underway and will be attached to this report.
Event or Problem Description
A shepherd.018 30g wire was used in an attempt to cross the proximal end of a complete total occlusion (cto) in the right superficial femoral artery.After multiple attempts to cross the cto with the wire, the wire broke during retraction, just proximal to the proximal 3cm tip.The fractured segment became stuck in a calcified branch or dissection plane.The fractured segment was unable to be removed and no snare was available.The procedure was aborted, and the patient was discharged after post procedure routine care.The patient was in stable condition.
Additional Manufacturer Narrative
Complaint investigation is attached to this report.

• Brand Name: 0.018" SHEPHERD 30 GUIDEWIRE - STRAIGHT 300 CM - 30 GMS
• Common Device Name: 0.018" SHEPHERD 30 GUIDEWIRE - STRAIGHT 300 CM - 30 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: 15923774
• Report Number: 3006010712-2022-00053
• Device Sequence Number: 17817378
• Product Code: DQX
• UDI-Device Identifier: 10850026568681
• UDI-Public: 10850026568681
• 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): 01/16/2023

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: 03/31/2025
• Device Model Number: 901068-12
• Device Catalogue Number: 7-10097-08
• Device Lot Number: 7174631
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2022
• Supplement Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 01/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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