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	Break (1069)
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
A diamondback 360 peripheral orbital atherectomy device (oad) was positioned on the wire and tested before entering the body.The crown of the oad was caught on a blue sterile towel.A replacement oad was used to complete the procedure.A shepherd peripheral guide wire tip broke off during the same procedure.
Additional Manufacturer Narrative
Complaint investigation underway and will be attached to this report.
Event or Problem Description
A diamondback 360 peripheral orbital atherectomy device (oad) was positioned on the wire and tested before entering the body.The crown of the oad was caught on a blue sterile towel.A replacement oad was used to complete the procedure.A shepherd peripheral guide wire tip broke off during the same procedure.
Additional Manufacturer Narrative
Complaint investigation is attached to this report.

• 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, 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: 18875128
• Report Number: 3006010712-2024-00016
• Device Sequence Number: 20813275
• 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
• Report Date (Section B): 04/22/2024

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: 07/30/2026
• Device Model Number: 901068-02
• Device Catalogue Number: 7-10096-02
• Device Lot Number: 8208035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/27/2024
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/21/2023
• 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