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

Model Number SR-014-GW

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 01/17/2022

Event Type  Injury  

Event Description

It was reported that during a transcarotid artery revascularization (tcar) procedure, a dissection was noted on the left common carotid artery caused by the enroute 0.014" guidewire which led the physician to place an additional stent over the dissection to resolve.The surgeon believes there was also unobserved plaque that the wire may have tracked behind.The patient's clinical condition after the completion of the procedure was reported as stable.

Event Description

It was reported that during a transcarotid artery revascularization (tcar) procedure, a dissection was noted on the left common carotid artery caused by the enroute 0.014" guidewire which led the physician to place an additional stent over the dissection to resolve.The surgeon believes there was also unobserved plaque that the wire may have tracked behind.The patient's clinical condition after the completion of the procedure was reported as stable.

• 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: 13509941
• MDR Text Key: 285563359
• Report Number: 3014526664-2022-00024
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 00811311020546
• UDI-Public: (01)00811311020546(17)311024(10)6141631
• 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: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• 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: 6141631
• 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: 02/10/2022
• Distributor Facility Aware Date: 01/17/2022
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female