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	04/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The subject microcatheter was returned for analysis and the device investigation revealed that polytetrafluoroethylene (ptfe) lining was peeled.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the subject microcatheter was returned with a stent loaded on the stent delivery wire (sdw) at the proximal end of the microcatheter.The stent could not be advanced through the subject microcatheter; however, it was able to be retracted back through the hub.There was an unknown material (possibly some sort of tubing like polytetrafluoroethylene (ptfe)) present on the sdw covering the distal bumper.The subject microcatheter shaft appeared to be stretched at the proximal end.For functional inspection, the subject microcatheter shaft was able to be flushed.A 0.023" pin gauge was verified to meet the subject microcatheter shaft when inserted into the subject microcatheter catheter hub, resistance was noted where the stent was located.A 0.0158" mandrel was unable to be advanced past where the stent was located within the subject microcatheter shaft.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 reported event was confirmed during device analysis.The device did not meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that the stent got stuck after being pushed into the subject microcatheter for about 10 centimeters, and the stent delivery wire could not be pushed forward.During analysis, the subject microcatheter was returned with a stent loaded on the stent delivery wire (sdw) at the proximal end of the microcatheter.The stent could not be advanced through the subject microcatheter; however, it was able to be retracted back through the hub.There was an unknown material (possibly some sort of tubing like polytetrafluoroethylene (ptfe)) present on the sdw covering the distal bumper.The subject microcatheter shaft appeared to be stretched at the proximal end.Based on a review of all available information and the analysis of the returned device it is probable that the subject microcatheter 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 as reported/as analysed 'catheter shaft friction' as well as the as analysed 'catheter shaft stretched' 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.

• 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 ; +1(510)413-2500
• MDR Report Key: 50184529
• Report Number: 3008881809-2026-00502
• Device Sequence Number: 13304262
• Product Code: DQY
• UDI-Device Identifier: 04546540688217
• UDI-Public: (01)04546540688217(17)270923(10)25825782
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K042568
• 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): 08/07/2026

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: 25825782
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/13/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/24/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2025
• 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: 62 YR
• Patient Sex: Male
• Patient Race: Asian