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	09/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection there was no visual damage noted to the catheter.During the functional inspection the device was flushed and an attempt to advance a 0.0158 mandrel failed.The catheter shaft was cut roughly 6cm from the hub and there was an unknown material (possibly polytetrafluoroethylene (ptfe)) removed with a mandrel.The mandrel was advance through the remainder of the catheter, a significant amount of blood 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 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.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 and continuous flush was set up and maintained throughout the clinical procedure.It was reported that the third and fourth coils could not be pushed through the subject catheter.After removing the microcatheter from the patient, the physician attempted to push a microwire through the catheter, but this was also unsuccessful.Based on a review of all available information and the analysis of the returned device it is probable that there may have been an issue with the flush during the procedure due to the presence of blood in the catheter causing the coils and guidewire to have difficulty advancing in the microcatheter.An assignable cause of procedural factors will be assigned to the reported event of the catheter, difficulty advancing coil and catheter difficulty advancing guidewire as well as the analyzed damage of catheter shaft blocked/occluded, catheter ptfe inner lining peeling and catheter shaft friction 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.
Event or Problem Description
The device was returned for analysis and the investigation of the device revealed that the guidewire (subject device) ptfe coating was peeling.No clinical consequences were reported to the patient due to this event.

• 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: 23633529
• Report Number: 3008881809-2025-00669
• Device Sequence Number: 10291065
• Product Code: DQY
• UDI-Device Identifier: 04546540688224
• UDI-Public: (01)04546540688224(17)270521(10)25629436
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 11/24/2025

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 Catalogue Number: M0031681900
• Device Lot Number: 25629436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2025
• 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
• Patient Sex: Unknown