MAUDE Adverse Event Report: LAKE REGION MEDICAL ENROUTE 0.014'' GUIDEWIRE

Model Number SR-014-GW

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem Vascular Dissection (3160)

Event Date 05/08/2023

Event Type  Injury  

Event Description

It was reported that during a transcarotid artery revascularization (tcar) procedure, a perforation occurred with the interventional wire (enroute 0.014'' guidewire), which was covered with an unplanned additional stent.The procedure was completed, and the patient was neurologically baseline.

• 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 Key: 16987908
• MDR Text Key: 315797955
• Report Number: 3014526664-2023-00080
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 00811311020546
• UDI-Public: (01)00811311020546(17)260831(10)7456837
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/22/2023,05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SR-014-GW
• Device Catalogue Number: SR-014-GW
• Device Lot Number: 7456837
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/22/2023
• Distributor Facility Aware Date: 05/08/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/11/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female