MAUDE Adverse Event Report: ENLIGHT MEDICAL TECHNOLOGIES (SHENZHEN) CO., LTD. WAVESELECT; CATHETER GUIDE WIRE

Model Number	GW1410
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
1.Product dhr confirmation: batch number :gw2504008, quantity: (b)(4) pieces.It is confirmed that there are no abnormalities in the production process, and the softness of the head end and the finished product inspection meet the requirements.2.As the product has not been returned, the appearance inspection, the softness test at the head end and the physical analysis cannot be carried out.Therefore, it is temporarily impossible to confirm that there are design or manufacturing defects in the product.After the incident, used trufill (cerenovus) and kaneka i ed coils to stop bleeding due to perforation.The operation was successfully completed without changing the product.Patient safely woke up and didnt show visual / physical deficits post procedure.3.During the process of advancing the guide wire during surgery, the control of the operation force and angle is extremely strict.Even minor deviations during the operation may lead to vascular perforation, which is a known operation-related risk in neurovascular interventional surgery.4.Such vascular perforation events have been included in the user manual and usefmea documents of neurovascular microguidewire products.They are expected surgical complications of intracranial interventional surgery and are closely related to factors such as the patient's vascular anatomical characteristics and the difficulty of surgical operation.The reported device has not been determined to have caused or contributed to the adverse event.This incident is being reported out of an abundance of caution.
Event or Problem Description
The physician was treating an acute subdural hematoma on a (b)(6) year old female patient and was advancing the guidewire through a headway duo 167cm (terumo) and as he was advancing, he reported a perforation in the mma artery.The physician used trufill (cerenovus) and kaneka i-ed coils to stop bleeding due to perforation.Patient safely woke up and didnt show visual / physical deficits post procedure.On (b)(6) 2025 the physician advised that the patient is stable and there has been no change in the outcome post procedure.Mfr report# 3034543750-2025-00001.

• Brand Name: WAVESELECT
• Common Device Name: CATHETER GUIDE WIRE
• Manufacturer (Section D): ENLIGHT MEDICAL TECHNOLOGIES (SHENZHEN) CO., LTD.; 5,6/f, buiding a, xinghui tec; 52 huaning r, dalang s; shenzhen,, guangdong 51810 9,; CH 518109,
• MDR Report Key: 23743272
• Report Number: 2435151-2025-00018
• Device Sequence Number: 13378153
• Product Code: MOF
• UDI-Device Identifier: 06945258302114
• UDI-Public: (01)06945258302114(17)280416(10)GW2504008
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/08/2025
• Report Date (Section F): 12/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: GW1410
• Device Catalogue Number: 102511
• Device Lot Number: GW2504008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/14/2025
• Event Location: Hospital
• Date Report to Manufacturer: 12/08/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/08/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HEADWAY DUO 167CM (TERUMO).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Date Report Sent to FDA: 12/08/2025