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	01/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stents would not go through the subject microcatheter.The subject catheter was returned for analysis and was examined.During device investigation and analysis, it was discovered that the subject catheter had ptfe inner lining peeling.There is no additional information available.
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 catheter was returned with two stents.The catheter shaft was noted to be kinked/bent.The catheter tip was noted to be flat/crushed.A stent was located at the proximal end of the catheter.The catheter was cut in order to retrieve the stent.There was an unknown material (possibly some sort of tubing like polytetrafluoroethylene (ptfe)) present on the distal end of the stent.During functional inspection the microcatheter shaft could not be flushed.A 0.023" pin gauge was verified to meet the catheter shaft when inserted into the catheter hub.A 0.0158" patency mandrel was advanced through the microcatheter, resistance was noted.The reported event ¿catheter shaft friction¿ was confirmed.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.It was reported that the stents would not go through the subject microcatheter.During analysis, the catheter was returned with two stents.The catheter shaft was noted to be kinked/bent.The catheter tip was noted to be flat/crushed.A stent was located at the proximal end of the catheter.The catheter was cut in order to retrieve the stent.There was an unknown material (possibly some sort of tubing like ptfe) present on the distal end of the stent.The microcatheter shaft could not be flushed.A 0.023" pin gauge was verified to meet the catheter shaft when inserted into the catheter hub.A 0.0158" patency mandrel was advanced through the microcatheter, resistance was noted.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 shaft friction¿ and to the analysed event ¿catheter shaft friction¿, ¿catheter shaft kinked/bent¿, ¿catheter shaft flat/crushed¿ ¿catheter ptfe inner lining peeling¿ and ¿device difficult to flush¿ 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.

• 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: 24873240
• Report Number: 3008881809-2026-00222
• Device Sequence Number: 9100583
• Product Code: DQY
• UDI-Device Identifier: 04546540688217
• UDI-Public: (01)04546540688217(17)271014(10)25866044
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K013789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/14/2026

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: 25866044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2025
• 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 Sex: Unknown