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	07/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The subject device was returned for analysis and the device investigation revealed that the catheter ptfe (polytetrafluoroethylene) inner lining was peeling.The subject device was replaced, and the procedure was completed successfully.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 catheter was returned with a stent deployed within the shaft.The catheter shaft was kinked/bent.The catheter distal tip was flat/crushed.The stent was located approximately 5cm from the proximal end.The catheter was cut in order to remove the stent.What appears to be catheter polytetrafluoroethylene (ptfe) inner lining was wrapped around the stent.During functional inspection a0.023" pin gauge was verified to meet the catheter shaft when inserted into the catheter hub.The microcatheter was flushed, a 0.0158" patency mandrel was unable to be advanced through the microcatheter due to the presence of the stent.Friction was noted at the damaged areas of the microcatheter.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 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 and continuous flush was set up and maintained throughout the clinical procedure.It was reported that when the stent was being advanced into the subject microcatheter, the physician found that it could not be pushed further.Based on a review of all available information and the analysis of the returned device it is probable that the ptfe inner layer was damaged when resistance was felt advancing the stent during the procedure.There may have been friction due to some procedural factors during use.An assignable cause of procedural factors will be assigned to the reported and analyzed event: 'catheter shaft friction' as well as the analyzed event 'catheter tip flat/crushed', 'catheter shaft kinked/bent', 'catheter shaft blocked/occluded' 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 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: 23349501
• Report Number: 3008881809-2025-00571
• Device Sequence Number: 15396307
• Product Code: DQY
• UDI-Device Identifier: 04546540688224
• UDI-Public: (01)04546540688224(17)260918(10)25191943
• 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): 10/21/2025

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 Expiration Date: 09/18/2026
• Device Catalogue Number: M0031681900
• Device Lot Number: 25191943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2024
• 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: 45 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Race: Asian