MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 PRE-SHAPED 45 150CM; CATHETER, PERCUTANEOUS

Catalog Number	M0031681900
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The catheter (subject device) was returned for analysis and it was discovered that the subject device ptfe (polytetrafluoroethylene) inner lining was removed (peeled) during use.
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the catheter shaft was kinked/bent in a number of locations.The catheter shaft was bent under the strain relief.The catheter tip was intact.The catheter hub was intact.During a functional inspection, a 0.023" pin gauge was verified to meet the catheter shaft when inserted into the catheter hub.The catheter was could not be flushed.A 0.0158" patency mandrel could not pass the proximal shaft below the hub but advanced distally until it met the same obstruction.After submerging the shaft in warm water, the mandrel still could not be advanced.The shaft was then cut, and material identified as what appeared to be ptfe (polytetrafluoroethylene) inner lining was removed.This material did not dissolve in water.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.The as reported event was confirmed based on analysis.The device did not meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information received indicated that the device was prepared for use as per the directions for use and continuous flush was maintained throughout the clinical procedure.Based on a review of all available information and the analysis of the returned device suggests that the ptfe inner layer was likely damaged when resistance occurred advancing the fourth coil.Three coils were placed successfully before this issue.The as reported 'catheter hub friction' as well as the analyzed 'catheter shaft kinked/bent', 'catheter shaft blocked/occluded', 'device difficult to flush', and 'catheter ptfe inner lining peeling' will be assigned procedural factors as this complaint appears 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 factors during use.

• Brand Name: EXCELSIOR SL-10 PRE-SHAPED 45 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: 25212381
• Report Number: 3008881809-2026-00311
• Device Sequence Number: 13405228
• Product Code: DQY
• UDI-Device Identifier: 04546540688224
• UDI-Public: (01)04546540688224(17)271130(10)25975647
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K042568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/19/2026

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: M0031681900
• Device Lot Number: 25975647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2025
• 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: COILS (UNKNOWN).
• Patient Sex: Unknown