MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR XT-17 STD STRAIGHT 150CM; Catheter, Percutaneous

Catalog Number	M003C1775ST0
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The microcatheter (subject device) was returned with the atlas stent device and the visual/microscopic inspection revealed that the sdw (stent delivery wire) of the atlas stent had pierced through the lumen/shaft of the subject microcatheter.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
This is 2 of 2 mdrs.

• Brand Name: EXCELSIOR XT-17 STD STRAIGHT 150CM
• Common Device Name: Catheter, Percutaneous
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): Stryker Neurovascular Cork; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; +1(510)413-2500
• MDR Report Key: 25398247
• Report Number: 3008881809-2026-00349
• Device Sequence Number: 17453268
• Product Code: DQY
• UDI-Device Identifier: 07613252714866
• UDI-Public: (01)07613252714866(17)270923(10)25865985
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142565
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: M003C1775ST0
• Device Lot Number: 25865985
• Date Returned to Manufacturer: 05/07/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Supplement Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 06/04/2026
• Supplement Report FDA Received Date: 08/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NEUROFORM ATLAS STENT (STRYKER).
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Race: Asian