MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 PRE-SHAPED 45 150CM; CATHETER, PERCUTANEOUS

Catalog Number	M0031681900
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
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/microscopic inspection, the distal tip of the microcatheter was noted to be broken/fractured with the radio opaque ro marker missing.There was dried blood noted at the fracture site.The hub was intact.During functional inspection, a 0.023" 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 advanced through the microcatheter, friction was noted at the tip of the microcatheter at the fracture site.There was no strand of fiber found on the microcatheter or within the returned packaging.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 could not be confirmed based on analysis of the device.However, the device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that upon withdrawal of subject microcatheter, a strand of fiber was noticed.During analysis, the distal tip of the subject microcatheter was noted to be broken/fractured with the ro marker missing, there was dried blood noted at the fracture site.A 0.023" 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 advanced through the microcatheter, friction was noted at the tip of the microcatheter at the fracture site.There was no strand of fiber found on the microcatheter or within the returned packaging.Based on a review of all available information and the analysis of the returned device it is probable that friction was encountered in the procedure causing the catheter tip to fracture during manipulation of the device.An assignable cause of not confirmed will be assigned to the as reported 'product contaminated (outside sterile barrier (pouch))', as the issue included a returned product review (visual, physical, and/or performance testing) which showed no evidence of either the alleged issue(s) or any defect which could have contributed to the event.An assignable cause of procedural factors will be assigned to the as analyzed 'catheter tip broken/fractured during use', 'ro marker(s) detached/separated/not visible under fluoroscopy' and 'catheter friction' 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
The subject catheter was returned for analysis and the device investigation revealed that the subject catheter tip was broken/fractured during use and ro marker(s) were detached/separated/not visible under fluoroscopy.There was no clinical consequence 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: 21947487
• Report Number: 3008881809-2025-00242
• Device Sequence Number: 8554170
• Product Code: DQY
• UDI-Device Identifier: 04546540688224
• UDI-Public: (01)04546540688224(17)260411(10)24893617
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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): 05/01/2025

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: 04/11/2026
• Device Catalogue Number: M0031681900
• Device Lot Number: 24893617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2024
• 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
• Patient Sex: Female