MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 PRE-SHAPED J 150CM; CATHETER, PERCUTANEOUS

Catalog Number	M0031681920
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guidewire encountered strong resistance when advanced into the subject catheter hub.The physician found out the subject catheter inner lumen has some problem (the coating is damaged).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 mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported event is covered in the device directions 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 complaint could not be confirmed and it could not be definitively determined if the device failed to meet specifications because the product was not returned.It was reported that the operator finished preparation on the subject microcatheter and tried to advance a guidewire into the catheter hub.Then he felt strong friction and worried if the microcatheter or guidewire was destroyed.He just used another new microcatheter with the existing guidewire and found out the first microcatheters inner lumen has some problem (ex.The coating is damaged).While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned to the as reported codes 'catheter ptfe inner lining peeling' and 'catheter hub friction'.
Event or Problem Description
It was reported that the guidewire encountered strong resistance when advanced into the subject catheter hub.The physician found out the the subject catheter inner lumen has some problem (the coating is damaged).The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: EXCELSIOR SL-10 PRE-SHAPED J 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: 21878817
• Report Number: 3008881809-2025-00224
• Device Sequence Number: 20784413
• Product Code: DQY
• UDI-Device Identifier: 04546540688248
• UDI-Public: (01)04546540688248(17)260123(10)24735499
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Followup
• Report Date (Section B): 06/19/2025

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: 01/23/2026
• Device Catalogue Number: M0031681920
• Device Lot Number: 24735499
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2024
• 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: SYNCHRO GUIDEWIRE (STRYKER).
• Patient Sex: Unknown