MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 STRAIGHT 2 TIP 150CM; CATHETER, PERCUTANEOUS

Catalog Number	M0031681890
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection the microcatheter was returned with a stent.The microcatheter shaft was not able to be flushed.A 0.0158" patency mandrel was not able to be advanced further than approximately 10cm from the proximal end.The microcatheter was cut, and a section of what appeared to be catheter polytetrafluoroethylene (ptfe) inner lining was removed.During functional inspection a 0.023" pin gauge was verified to meet the catheter shaft when inserted into the catheter hub.A 0.0158" patency mandrel was unable to be advanced fully through the microcatheter.The reported event ¿catheter hub friction' could not be replicated.However, the analysis results are consistent with the reported event.The reported event is covered in the device direction for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.Additional information provided by the customer indicated that the device was prepared for use as per the directions for use, there was no damage noted to the packaging prior to opening the packaging, the device confirmed to be in good condition during preparation/prior to use on the patient and continuous flush was set up and maintained throughout the clinical procedure.It was reported that when the stent was being delivered into the hub of the microcatheter, excessive resistance was encountered, preventing normal introduction.During analysis, the subject microcatheter was returned with a stent.The microcatheter shaft was not able to be flushed.A 0.0158" patency mandrel was not able to be advanced further than approximately 10cm from the proximal end.The microcatheter was cut, and a section of what appeared to be catheter ptfe inner lining was removed.A 0.023" pin gauge was verified to meet the catheter shaft when inserted into the catheter hub.A 0.0158" patency mandrel was unable to be advanced fully through the microcatheter.Based on a review of all available information and the analysis of the returned device it is probable that the catheter shaft was damaged during manipulation of the device during the procedure when resistance was encountered transferring the stent.It is probable that there may have been movement of the stent introducer sheath during the transfer attempt, causing the difficulty to transfer the stent.An assignable cause of procedural factors will be assigned to the reported event ¿catheter hub friction' and to the analyzed event 'catheter shaft friction' and ¿catheter ptfe inner lining peeling' as these issues are associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
It was reported that during a procedure for an intracranial aneurysm, when the stent was being delivered into the hub of the subject microcatheter, excessive resistance was encountered, preventing normal introduction.However, the subject catheter was returned for analysis, and the device investigation revealed that the subject catheter had ptfe inner lining peeling.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: EXCELSIOR SL-10 STRAIGHT 2 TIP 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 ; 5104132500
• MDR Report Key: 24513781
• Report Number: 3008881809-2026-00122
• Device Sequence Number: 9746139
• Product Code: DQY
• UDI-Device Identifier: 04546540688217
• UDI-Public: (01)04546540688217(17)270521(10)25629458
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K013789
• 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
• Report Date (Section B): 03/04/2026

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: M0031681890
• Device Lot Number: 25629458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2025
• 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: 54 YR
• Patient Sex: Male
• Patient Race: Asian