MAUDE Adverse Event Report: MICROVENTION INC. TRAXCESS-14; WIRE GUIDE CATHETER

Model Number	GW1420040
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	11/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was discarded at the user facility and not returned to the manufacturer for evaluation.However, imaging was provided.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.This report addresses the guide wire used in the same procedure as the reported clot retriever device that is referenced under mfr report # 2032493-2024-00943.
Event or Problem Description
It was reported that during treatment for an ischemic stroke, a guidewire broke inside the patient.The guidewire was able to be removed using a snare device.The patient¿s condition remains the same with a stroke scale of nihss 20.There is no additional information available for this case.
Additional Manufacturer Narrative
Procedure/medical information review: fifteen radiographic images are submitted.None are labeled as to time or day.All are small files and relatively blurry; all the images were taken with a cell phone of the monitor in the control room.All are single shots without contrast except for images 14 and 15 which are superselective subtracted angiograms with contrast.All the images are very coned down on the devices.P24-7318 fluoroscopic image 1: lateral.Stent retriever in m3 (i can¿t tell which, image is blurry).P24-7318 fluoroscopic image 2: ap, guide catheter in ica siphon, dac in proximal m1.Microwire with tip in m3.P24-7318 fluoroscopic image 3: lateral.There is a stent retriever in m3 (i can¿t tell which, image is blurry).P24-7318 fluoroscopic image 4: ap.Same as image 2.P24-7318 fluoroscopic image 5: lateral.Microcatheter close to base of retriever.Proximal retriever appears ¿bunched up¿.P24-7318 fluoroscopic image 6: same as image 5.P24-7318 fluoroscopic image 7: ap.Stent retriever is now in proximal m2.P24-7318 fluoroscopic image 8: lateral.Same as image 7.P24-7318 fluoroscopic image 9: ap.Same as image 8.P24-7318 fluoroscopic image 10: ap.Stent retriever seen in proximal m2 (i can¿t tell which, image is blurry).P24-7318 fluoroscopic image 11: ap magnified.Same as image 10.P24-7318 fluoroscopic image 12: lateral.Microcatheter and guidewire seen in distal parietal m3/m4 area.P24-7318 fluoroscopic image 13: ap.Same as image 12.P24-7318 fluoroscopic image 14: lateral superselective dsa of parietal branch.Contrast exits the catheter, is seen for a few cm, and then stops, either because of distal obstruction by clot, vasospasm, or because the microcatheter is wedged.P24-7318 fluoroscopic image 15: ap.Same as image 14.These images provide less detail than the description of the event, and do not explain why the eric and traxcess broke off.The eric was placed very distally and this is at least one explanation as to why it was difficult to retrieve.Investigation findings: without the return and physical evaluation of the device, the investigation cannot further examine if a condition existed that would have contributed to the reported event.Batch review: history investigation of the involved product code and lot#: · no anomaly was found in the manufacturing record and the shipping inspection record.· no similar event was found in the past complaint file.Based on a review of the device¿s risk documentation, the reported event did not indicate there were the presence of any potential or new manufacturing, design, quality, or other systemic issues, or non-conformances.The complaint code is monitored through the trending process; corrective action is determined, as needed, through this process.Investigations of historic complaint files with similar complaint category coding are recorded in the complaint handling system; without the ability to perform an analysis of the device, this investigation cannot identify with certainty any potential root causes.Ashitaka factory is committed to maintaining the product quality through the following control measures: · after the product assembly, 100% visual inspection is performed to confirm that there is no deformation.· after the product assembly, the outer diameter of the coiled section is measured on 100% basis to confirm that there is no anomaly in it.· as a shipping inspection, it is confirmed that there is no anomaly in the bending strength.
Event or Problem Description
Additional information was provided that stated the patient's anatomy was tortuous which made it difficult to remove and it broke.The patient's condition remains the same as stroke scale of nihss 20.No further information is available for this case.

• Brand Name: TRAXCESS-14
• Common Device Name: WIRE GUIDE CATHETER
• Manufacturer (Section D): MICROVENTION INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 21044512
• Report Number: 2032493-2024-00945
• Device Sequence Number: 3493508
• Product Code: DQY
• UDI-Device Identifier: 00810170012280
• UDI-Public: (01)00810170012280(11)211202(17)241130(10)211202
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K080863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Model Number: GW1420040
• Device Lot Number: 211202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 01/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Required Intervention
• Patient Sex: Unknown