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	02/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The subject catheter was returned for analysis and the device investigation revealed that the subject catheter ptfe polytetrafluoroethylene inner lining was peeled.There were no clinical consequences to the patient reported as a result of this event.
Additional Manufacturer Narrative
This is 4/4 mdrs 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/microscopic inspection, the microcatheter was returned with stent deployed within the lumen at the proximal end.The stent was removed by advancing a 0.0158" mandrel through the distal end of the microcatheter.Resistance was noted while retracting the mandrel through the microcatheter near the proximal end.The microcatheter was cut at this point and there was an unknown material (possibly some sort of tubing like polytetrafluoroethylene ptfe) removed from the shaft.During functional inspection, the microcatheter shaft could 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 able to be completely advanced through the microcatheter, resistance 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 event was confirmed based on analysis of the returned device.The device failed to meet specification when returned for analysis.It was reported that ¿an attempt was made to insert the stent under the radial approach.However, the stent got stuck within the subject microcatheter.The stent was removed with the entire microcatheter.Then another one of the stent was inserted into the other one of the microcatheter; however, the same issue occurred.Again, the stent was removed with the entire microcatheter, and both devices were replaced with new ones, then changed to femoral approach, then the procedure was successfully completed¿.Additional information provided indicated flush was given when the product was taken out from the dispenser hoop, friction/resistance was noted in the shaft of the microcatheter, and it was unknown if an introducer was used when inserting another device into this product or inserting this product into another device.Analysis of the returned device indicated the microcatheter was returned with a stent deployed within the lumen at the proximal end.The stent was removed by advancing a 0.0158" mandrel through the distal end of the microcatheter.Resistance was noted while retracting the mandrel through the microcatheter near the proximal end.The microcatheter was cut at this point and there was an unknown material (most likely ptfe) removed from the shaft.Based on the available information and the analysis of the returned device, it is probable that the event may have resulted from procedural factors during the procedure as the anatomy was severely tortuous.The as reported ¿catheter shaft friction¿ and as analyzed ¿catheter shaft friction¿ and 'catheter ptfe inner lining peeling¿ will be assigned procedural factors as these defects appear to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural or anatomical factors during use.

• 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: 25124384
• Report Number: 3008881809-2026-00289
• Device Sequence Number: 10729159
• Product Code: DQY
• UDI-Device Identifier: 04546540688217
• UDI-Public: (01)04546540688217(17)271011(10)25866042
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/08/2026

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: 25866042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2025
• 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: ATLAS STENT (STRYKER)
• Patient Sex: Unknown