Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LAKE REGION MEDICAL 0.018 SHEPHERD GUIDEWIRE - STRAIGHT 300 CM - 6 GMS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

LAKE REGION MEDICAL 0.018 SHEPHERD GUIDEWIRE - STRAIGHT 300 CM - 6 GMS Back to Search Results
Model Number 901068-16
Device Problem Difficult to Advance (2920)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 02/26/2024
Event Type  malfunction  
Event 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.
 
Manufacturer Narrative
Complaint investigation underway and will be attached to this report.
 
Event 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.
 
Manufacturer Narrative
Complaint investigation is attached to this report.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
0.018 SHEPHERD GUIDEWIRE - STRAIGHT 300 CM - 6 GMS
Type of Device
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 Key18874685
MDR Text Key337320697
Report Number3006010712-2024-00014
Device Sequence Number1
Product Code DQX
UDI-Device Identifier10850026568605
UDI-Public10850026568605
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120137
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Administrator/Supervisor
Remedial Action Other
Type of Report Initial
Report Date 03/04/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number901068-16
Device Catalogue Number7-10096-08
Device Lot Number8015988
Was Device Available for Evaluation? No
Date Manufacturer Received02/26/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/15/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-