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	05/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was initially reported that during pcoma aneurysm coil embolization procedure, when the stent was advancing through the subject microcatheter, the stent got stuck in the middle of the subject microcatheter.The physician withdrew the stent together with the subject microcatheter out of the body, switched to a different brand of microcatheter and stent, and the procedure was successfully completed.The subject catheter was returned for analysis and examined.The returned catheter showed peeling of its polytetrafluoroethylene (ptfe) inner lining during investigation.No clinical consequences to the patient were reported.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system, there are controls in the manufacturing process to ensure the product met specifications upon release.Visual/microscopic inspection was performed as the subject microcatheter was returned with the stent deployed at the proximal end of the catheter shaft (subject device).The subject microcatheter was cut to remove the stent.There was an unknown material (potentially polytetrafluoroethylene ¿ptfe¿) present at the distal end of the stent and in the middle of the stent.The subject microcatheter was unable to 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 subject microcatheter; resistance was noted when the stent was located.The as reported event was confirmed during analysis.The returned subject 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 returned device was prepared for use as per the directions for use and continuous flush was maintained throughout the clinical procedure.Based on the available information and analysis of the returned device, it is likely that the ptfe inner layer was damaged when resistance was encountered while advancing the stent during the procedure.The concurrent stent may have sustained damage during transfer as a result of procedural factors, which could have contributed to the reported resistance.Additional damage to the subject microcatheter inner layer may have occurred during cutting of the catheter shaft.The as reported 'catheter shaft friction' as well as the analyzed ¿catheter shaft friction', ¿catheter ptfe inner lining peeling' and ¿device difficult to flush' will be assigned a probable assignable cause of 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.Note: this mdr report refers to excelsior sl-10 straight 2 tip 150cm.

• 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: 50850070
• Report Number: 3008881809-2026-00586
• Device Sequence Number: 18518694
• Product Code: DQY
• UDI-Device Identifier: 04546540688217
• 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): 09/22/2026

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: 25934476
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/25/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2025
• 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
• Patient Race: Asian