MAUDE Adverse Event Report: LAKE REGION MEDICAL 0.018" SHEPHERD 12 GUIDEWIRE - STRAIGHT 300 CM - 12 GMS

Model Number	901068-08
Medical Device Problem Codes	Fracture (1260); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint investigation underway.
Event or Problem Description
A shepherd guide wire was inserted into a 0.035 navicross 90cm angled catheter, along with a mongo guide wire in a side branch from a retrograde pedal sheath in the dorsalis pedis artery.Once the shepherd guide wire was inserted and navigated into a tortuous, diseased subintimal arterial space, the mongo guide wire was retracted ex-vivo with some resistance.The tip of the shepherd guide wire was bent distal to the radiopaque portion of the wire.The physician attempted to pull the shepherd guide wire out of the navicross catheter when the wire fractured.The fractured component was unable to be retrieved and remained in subintimal space.
Event or Problem Description
A shepherd guide wire was inserted into a 0.035 navicross 90cm angled catheter, along with a mongo guide wire in a side branch from a retrograde pedal sheath in the dorsalis pedis artery.Once the shepherd guide wire was inserted and navigated into a tortuous, diseased subintimal arterial space, the mongo guide wire was retracted ex-vivo with some resistance.The tip of the shepherd guide wire was bent distal to the radiopaque portion of the wire.The physician attempted to pull the shepherd guide wire out of the navicross catheter when the wire fractured.The fractured component was unable to be retrieved and remained in subintimal space.

• Brand Name: 0.018" SHEPHERD 12 GUIDEWIRE - STRAIGHT 300 CM - 12 GMS
• Common Device Name: 0.018" SHEPHERD 12 GUIDEWIRE - STRAIGHT 300 CM - 12 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: 15804543
• Report Number: 3006010712-2022-00049
• Device Sequence Number: 5612695
• Product Code: DQX
• UDI-Device Identifier: 10850026568643
• UDI-Public: 10850026568643
• 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): 01/09/2023

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: 04/30/2025
• Device Model Number: 901068-08
• Device Catalogue Number: 7-10097-04
• Device Lot Number: 7174560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/11/2022
• Supplement Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 11/16/2022
• Supplement Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2022
• 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