MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR XT-27 STD PRE-SHAPED 150CM; CATHETER, PERCUTANEOUS

Catalog Number	M003XT2750910
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Analysis of the returned microcatheter device was found that the shaft of the subject microcatheter device was broken/fractured during use.There was no clinical consequence 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 analysis, the subject microcatheter was returned with a stent.The shaft of the subject microcatheter was kinked/bent and broken/fractured under the primary strain relief.The distal tip of the stent delivery wire was located within the lumen of the hub section (subject microcatheter).The reported complaint was confirmed based on analysis the device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.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.Additional information provided by the customer indicated that there was no damage noted to the packaging prior to opening the packaging, the subject device was confirmed to be in good condition during preparation/prior to use on the patient, the subject device was prepared for use as per the directions for use, continuous flush was set up and maintained throughout the clinical procedure.The patients anatomy was severely tortuous.It was reported that an attempt was made to advance a stent through the subject microcatheter; however, difficulty was encountered when introducing the stent into the subject microcatheter, and after multiple attempts, the attempt failed due to the subject microcatheter occlusion.During the removal process, the hub connection of the subject microcatheter broke, resulting in separation of the hub from the microcatheter shaft.During analysis, the subject microcatheter was returned with a stent.The shaft of the subject microcatheter was kinked/bent and was broken/fractured under the primary strain relief.The distal tip of the stent delivery wire was located within the lumen of the hub section (subject microcatheter).Based on a review of all available information and the analysis of the returned subject microcatheter device it is probable that manipulation of the subject device due resistance would have caused the damage noted during analysis.The complaint was reported for hub broken/fracture; however, the location of the fracture on the subject catheter shaft would have been perceived as hub fracture.An assignable cause of procedural factors will be assigned to the as reported 'catheter hub friction', 'catheter hub broken/fractured' and the as reported/as analyzed ' catheter hub blocked/occluded' as well as the as analyzed 'catheter shaft broken/fractured during use' and 'catheter shaft kinked/bent' 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.This is 2 of 2 mdr reports.

• Brand Name: EXCELSIOR XT-27 STD PRE-SHAPED 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: 24537159
• Report Number: 3008881809-2026-00131
• Device Sequence Number: 10372335
• Product Code: DQY
• UDI-Device Identifier: 04546540698155
• UDI-Public: (01)04546540698155(17)271002(10)25210428
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113778
• 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): 03/06/2026

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: M003XT2750910
• Device Lot Number: 25210428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2024
• 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 EZ STENT (STRYKER).; SYNCHRO GUIDEWIRE (STRYKER).
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Race: Asian