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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LAKE REGION MEDICAL ENROUTE 0.014'' GUIDEWIRE
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LAKE REGION MEDICAL ENROUTE 0.014'' GUIDEWIRE Back to Search Results
Model Number SR-014-GW
Device Problems Device Damaged Prior to Use (2284); Material Twisted/Bent (2981)
Patient Problem Vascular Dissection (3160)
Event Date 01/31/2024
Event Type  Injury  
Event Description
It was reported that during a transcarotid artery revascularization (tcar) procedure, the enroute 0.014" guidewire buckled over in the arterial sheath during advancement, leading to a dissection in the common carotid artery (cca).The physician re-accessed the vessel and placed a larger stent to cover the repaired flap in the cca.Further details revealed that the guidewire was kinked when removed from the packaging, yet the device was still used in the procedure.The procedure was completed successfully with no further complications.
 
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Brand Name
ENROUTE 0.014'' GUIDEWIRE
Type of Device
0.014'' GUIDEWIRE
Manufacturer (Section D)
LAKE REGION MEDICAL
parkmore west business park
galway, 91385 037
EI  91385037
MDR Report Key18773702
MDR Text Key336178642
Report Number3014526664-2024-00046
Device Sequence Number1
Product Code DQX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 02/23/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberSR-014-GW
Device Catalogue NumberSR-014-GW
Device Lot Number8210223
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/23/2024
Distributor Facility Aware Date01/31/2024
Event Location Hospital
Date Report to Manufacturer02/12/2024
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age74 YR
Patient SexFemale
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