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

Catalog Number	M003XT2750810
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the subject microcatheter was used to assist in the deployment of the flow diverter stent.After the physician had successfully positioned the subject microcatheter, they introduced a flow diverter stent from into the subject microcatheter.When attempting to advance the stent from the proximal end at the hub of the subject microcatheter, the physician encountered significant resistance and was unable to proceed despite multiple attempts.Upon observation, it was found that the proximal end of the subject microcatheter had fractured.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
D4 expiration date: updated d4 gtin: updated d9 product available to stryker: updated d9 returned to manufacturer on: updated h3 device evaluated by mfg: updated.H4 manufacturing date: updated.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 visual inspection, the subject microcatheter shaft was fractured just below the hub.The subject microcatheter shaft was seen to be flat in numerous areas.Functional inspection was not performed.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 was confirmed based on analysis of the device.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported "when using a subject microcatheter to assist in the deployment of a flow diverter (fd) stent for the treatment of an intracranial aneurysm, after the physician had successfully positioned the subject microcatheter, they introduced an fd stent from the domestic brand into the subject microcatheter.When attempting to advance the fd stent from the proximal end at the hub of the subject microcatheter, the physician encountered significant resistance and was unable to proceed despite multiple attempts.Upon observation, it was found that the proximal end of the subject microcatheter had fractured.Consequently, the physician replaced it with a new microcatheter and completed the procedure.".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, the device confirmed to be in good condition during preparation/prior to use on the patient and continuous flush was set up and maintained throughout the clinical procedure.The subject microcatheter shaft was fractured directly below the hub.The subject microcatheter shaft was seen to be flat/crushed in numerous areas.Based on a review of all available information and the analysis of the returned device it is probable that the catheter shaft was fractured when resistance was felt introducing an fd stent from the domestic brand into the subject microcatheter.The flow diverter dimensions are unknown.The reported 'catheter shaft broken/fractured during use' and 'catheter hub friction' as well as the analysed 'catheter shaft broken/fractured during use' and 'catheter shaft flat/crushed' will be assigned procedural factors 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 anatomical factors during use, the product performance was limited.
Event or Problem Description
It was reported that during the procedure, the subject microcatheter was used to assist in the deployment of the flow diverter stent.After the physician had successfully positioned the subject microcatheter, they introduced a flow diverter stent from into the subject microcatheter.When attempting to advance the stent from the proximal end at the hub of the subject microcatheter, the physician encountered significant resistance and was unable to proceed despite multiple attempts.Upon observation, it was found that the proximal end of the subject microcatheter had fractured.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 XT-27 STD STRAIGHT 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: 24311054
• Report Number: 3008881809-2026-00078
• Device Sequence Number: 5650536
• Product Code: DQY
• UDI-Device Identifier: 04546540698131
• UDI-Public: (01)04546540698131(17)280531(10)25642963
• 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,Followup
• Report Date (Section B): 03/19/2026

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: M003XT2750810
• Device Lot Number: 25642963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2026
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2025
• 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: FLOW DIVERTER STENT (ACANDIS).
• Patient Sex: Unknown
• Patient Race: Asian