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

Model Number	901068-16
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The shepherd guide wire could not be advanced through a chronic total occlusion (cto) in a very calcified anterior tibial (at) artery.The physician attempted to push the wire in order to advance it through the cto.The wire became stuck when removing it from the non-csi 0.035 support catheter and fractured in vivo at the radiopaque tip.Using a 2.5 mm x 100 mm jade balloon, the balloon was deflated when attempting to remove the fragment from the vessel.The fragment was embedded in the sub-medial portion of the vessel preventing the use of a snare.The fragment remains in the chronic total occlusion segment of the distal right at.The lesion was not treated, and the procedure was completed.A procedure is planned for another angiogram with intervention utilizing an antegrade approach to cross the at.The patient is in rest pain per critical limb ischemia criteria.
Additional Manufacturer Narrative
Complaint investigation underway and will be attached to this report.
Event or Problem Description
The shepherd guide wire could not be advanced through a chronic total occlusion (cto) in a very calcified anterior tibial (at) artery.The physician attempted to push the wire in order to advance it through the cto.The wire became stuck when removing it from the non-csi 0.035 support catheter and fractured in vivo at the radiopaque tip.Using a 2.5 mm x 100 mm jade balloon, the balloon was deflated when attempting to remove the fragment from the vessel.The fragment was embedded in the sub-medial portion of the vessel preventing the use of a snare.The fragment remains in the chronic total occlusion segment of the distal right at.The lesion was not treated, and the procedure was completed.A procedure is planned for another angiogram with intervention utilizing an antegrade approach to cross the at.The patient is in rest pain per critical limb ischemia criteria.

• 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: 16580799
• Report Number: 3006010712-2023-00012
• Device Sequence Number: 4681345
• 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): 06/01/2023

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: 08/31/2025
• Device Model Number: 901068-16
• Device Catalogue Number: 7-10096-08
• Device Lot Number: 7514894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2023
• Supplement Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2022
• 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