MAUDE Adverse Event Report: LAKE REGION MEDICAL 0.018 SHEPHERD GUIDEWIRE - STRAIGHT 300 CM - 6 GMS

Model Number	901068-16
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The shepard wire was advanced through a 018 navicross catheter but became stuck and could not be advanced through.When removing the shepard wire, the wire coating was damaged and peeled off.No components were left in vivo.A second shepard wire was used and was successfully advanced to the superficial femoral artery (sfa).When removing the second shepard wire, it became stuck inside the navicross catheter.Both were removed together.A new navicross catheter and a asahi guide wire were used to complete the procedure.The patient was stable and did not experience any impact from the reported issues.
Additional Manufacturer Narrative
Complaint investigation underway and will be attached to this report.
Additional Manufacturer Narrative
Complaint investigation is attached to this report.
Event or Problem Description
The shepard wire was advanced through a 018 navicross catheter but became stuck and could not be advanced through.When removing the shepard wire, the wire coating was damaged and peeled off.No components were left in vivo.A second shepard wire was used and was successfully advanced to the superficial femoral artery (sfa).When removing the second shepard wire, it became stuck inside the navicross catheter.Both were removed together.A new navicross catheter and a asahi guide wire were used to complete the procedure.The patient was stable and did not experience any impact from the reported issues.

• 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): 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: 18874930
• Report Number: 3006010712-2024-00015
• Device Sequence Number: 9255853
• Product Code: DQX
• UDI-Device Identifier: 10850026568605
• UDI-Public: 10850026568605
• 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): 04/15/2024

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 Expiration Date: 04/30/2026
• Device Model Number: 901068-16
• Device Catalogue Number: 7-10096-08
• Device Lot Number: 8015988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2023
• 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