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	01/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is 2nd of 2 mdr.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 received with a stent deployed within the proximal lumen.The subject microcatheter was cut in order to remove the stent.Polytetrafluoroethylene (ptfe) from the subject microcatheter inner lumen was present on the stent.For functional inspection, the subject microcatheter shaft was able 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 advanced fully through the microcatheter, resistance was noted.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 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.Additional information provided by the customer indicated that the device was prepared for use as per the directions for use, there was no damage noted to the packaging prior to opening the packaging, the device confirmed to be in good condition during preparation/prior to use on the patient.It was reported " during the delivery process, the stent deployed prematurely inside the subject microcatheter and could not be advanced out of it.The physician then withdrew this subject microcatheter and stent system, replaced them with a new stent and microcatheter, and successfully completed the procedure.".Additional information did not indicate any issues noted during unpacking or set up of the device, the device was prepared as per dfu instructions and continuous flush was set up and maintained throughout the clinical procedure.The anatomy was reported to be moderately tortuous which most likely contributed to the reported event.The stent was received deployed within the proximal lumen of a subject microcatheter.The microcatheter was cut and a 0.0158" mandrel was used to push the stent out.The stent was deformed at the proximal end, and had inner liner from the subject microcatheter lumen (appears to be polytetrafluoroethylene (ptfe) from the microcatheter).Based on a review of all available information and the analysis of the returned device it is probable that there may have been movement of the stent introducer sheath during the transfer attempt, causing the friction and difficulty to transfer the stent.An assignable cause of procedural factors will be assigned to the reported/ analysed ¿catheter shaft friction' and the analysed 'catheter shaft friction' and 'catheter ptfe inner lining peeling' as the issue is 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.
Event or Problem Description
It was reported that during the procedure, resistance was encountered by the stent at the proximal part of the subject microcatheter while advancing the stent into it.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.The subject device was returned for analysis and the device investigation revealed that the polytetrafluoroethylene (ptfe) inner lining of the subject microcatheter was peeled.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: 24646248
• Report Number: 3008881809-2026-00154
• Device Sequence Number: 9760618
• Product Code: DQY
• UDI-Device Identifier: 04546540688217
• UDI-Public: (01)04546540688217(17)270626(10)25712603
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 03/19/2026

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: M0031681890
• Device Lot Number: 25712603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2025
• 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