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	11/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report 2 of 2 mdr (2nd mdr).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, it was noted that the catheter was returned with an subject stent deployed within the hub/lumen.The microcatheter 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 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 completely through the microcatheter due to the presence of blood.Friction was noted at the proximal end.The reported event is covered in the device directions 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.The reported defect was confirmed based on analysis of the device.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The reported event was reported that the stent detached from the subject catheter prematurely.During analysis, the subject catheter was returned with a stent deployed within the hub/lumen.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.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 completely through the microcatheter due to the presence of blood.Friction was noted at the proximal end.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 transferring the stent.It is probable that there may have been movement of the stent introducer sheath during the transfer attempt, causing the stent to deploy prematurely.An assignable cause of procedural factors will be assigned to the reported event "device problem unknown/unclear' as well as the analyzed event 'catheter shaft friction', 'catheter shaft blocked/occluded' 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 directions for use but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
The subject catheter was returned for analysis and the device investigation revealed that the subject catheter ptfe inner lining peeling.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: 24090925
• Report Number: 3008881809-2026-00029
• Device Sequence Number: 10259530
• Product Code: DQY
• UDI-Device Identifier: 04546540688217
• UDI-Public: (01)04546540688217(17)270708(10)25713084
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/16/2026

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: 25713084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2025
• 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 (STRYKER)
• Patient Sex: Unknown