MAUDE Adverse Event Report: Stryker Neurovascular Cork EXCELSIOR XT-27 STD PRE-SHAPED 150CM; Catheter, Percutaneous, Neurovasculature

Catalog Number	M003XT2750910
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the microcatheter (subject device) was used in the treatment of opthalmic artery aneurysm procedure.After the stent was advanced to the midsection of the subject microcatheter, resistance was encountered.The physician then increased the pushing force resulting in fracture to the hub of the subject device.The subject device was then withdrawn and replaced, and the procedure was reported to be completed successfully without any clinical consequence to the patient.However, when the subject device was returned for analysis the shaft of the subject device was observed to be kinked/bent, flat/crushed and had friction at the damaged sections.Also, the shaft of the subject device was noted to be broken/fractured.
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, the catheter shaft was noted to be kinked/bent.The catheter shaft was noted to be flat/crushed.The catheter shaft was broken/fractured under the primary strain relief.As a part of functional inspection, a 0.027" pin gauge was inserted into the catheter hub without issue.The catheter could not be flushed as the catheter shaft was broken at the hub.A 0.0265" patency mandrel was advanced through the microcatheter, resistance was encountered in areas of damage.The reported event of 'catheter hub broken/fractured' could not be replicated.However, the analysis results are consistent with the reported event.The reported event of 'catheter shaft friction' was confirmed.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.It was reported that during stent delivery, the stent encountered resistance after being delivered to the mid-segment of the subject microcatheter.The physician continued to push, and the resistance increased.The physician increased the pushing force to attempt advancement, at which point the hub of the microcatheter fractured.Based on a review of all available information and the analysis of the returned device it is probable that manipulation of the 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 catheter shaft would have been perceived as hub fracture.An assignable cause of procedural factors will be assigned to the reported event of 'catheter hub broken/fractured' and the reported and analysed event of 'catheter shaft friction' as well as the analysed events of 'catheter shaft kinked/bent', 'catheter shaft flat/crushed', and 'catheter shaft broken/fractured' 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.

• Brand Name: EXCELSIOR XT-27 STD PRE-SHAPED 150CM
• Common Device Name: Catheter, Percutaneous, Neurovasculature
• 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 ; +1(510)413-2500
• MDR Report Key: 50892962
• Report Number: 3008881809-2026-00598
• Device Sequence Number: 12262438
• Product Code: QJP
• UDI-Device Identifier: 04546540698155
• UDI-Public: (01)04546540698155(17)281208(10)26007148
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K242289
• 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): 09/24/2026

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: 26007148
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/17/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Lattice Flow Diverter Stent (Non-Stryker); Synchro Guidewire (Stryker)
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Race: Asian