MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR XT-27 STD PRE-SHAPED 150CM; CATHETER, PERCUTANEOUS22

Catalog Number	M003XT2750910
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
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 inspection the microcatheter was returned with a flow diverter stent.The microcatheter shaft was broken/fractured with the braid and ptfe inner lining exposed 15.9cm from the distal end.Further breaks/fractures were noted along the microcatheter shaft 14.5cm, 12.6cm, 4.2cm from the distal end.The microcatheter shaft was kinked/bent 5.5cm and 7.1cm from the distal end.The shaft at the microcatheter distal end appeared to be melted.During functional inspection the microcatheter was flushed and a 0.027" pin gauge was inserted into the hub without difficulties, it met the proximal end of the catheter shaft when inserted into the microcatheter hub.The microcatheter was flushed again and a 0.0265" patency mandrel was advanced through the microcatheter and could not be advanced passed the break/fracture 15.9cm from the distal end.The reported event ¿catheter shaft friction' could not be replicated; however, the analysis results are consistent with the reported event.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 ¿after advancing the microcatheter past the lesion, when deploying a stent in place and pushing it out by approximately two-thirds, the physician encountered abnormal resistance, and the distal end of the stent failed to open normally¿.Additional information provided by the customer did not indicate any issues noted during unpacking or set up of the device, and the device was prepared as per dfu instructions.The dispenser hoop was flushed before removing the catheter and there was no resistance encountered removing the catheter from the dispenser hoop.There was no indication of a user related issue.The anatomy was reported to be moderately tortuous.The catheter was flushed to facilitate the stent insertion.There was friction encountered within the catheter shaft.The flow diverter was recaptured back into the microcatheter four times.Product analysis found the microcatheter was returned with a stent.The microcatheter shaft was broken/fractured with the braid and polytetrafluoroethylene (ptfe) inner lining exposed 15.9cm from the distal end.Further breaks/fractures were noted along the microcatheter shaft 14.5cm, 12.6cm, 4.2cm from the distal end.The microcatheter shaft was kinked/bent 5.5cm and 7.1cm.The shaft at the microcatheter distal end appeared to be melted which indicates the microcatheter encountered a heat source possibly during an attempt to shape the tip of the microcatheter.The microcatheter was flushed and a 0.027" pin gauge was inserted into the hub without difficulty, it met the proximal end of the catheter shaft when inserted into the microcatheter hub.When a 0.0265" patency mandrel was advanced through the microcatheter, it could not be advanced passed the break/fracture 15.9cm from the distal end.It should be noted according to the additional information, the flow diverter was recaptured/resheathed back during the procedure four times which indicates the microcatheter appeared to be functioning at intended and could not have been so significantly damaged at this point.It is possible the melted/damaged catheter distal end may have compromised the microcatheter and led to the "abnormal resistance" experienced when pushing out the stent from the microcatheter by approximately two-thirds.The extensive damage to the microcatheter shaft indicates the device encountered a significant force during use to have caused such damage.An assignable cause of procedural factors will be assigned to the reported event ¿catheter shaft friction¿ and to the analysed event ¿catheter shaft broken/fractured during use¿, ¿catheter shaft kinked/bent¿ and ¿ catheter shaft damaged¿ 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
It was reported that during a procedure for a right internal carotid artery ophthalmic segment aneurysm, that when deploying a stent in place and pushing it out by approximately two-thirds, the physician encountered abnormal resistance within the subject microcatheter.The subject device was returned for analysis and the device investigation revealed that the subject catheter shaft was broken/fractured during use.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 PRE-SHAPED 150CM
• Common Device Name: CATHETER, PERCUTANEOUS22
• 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: 24801582
• Report Number: 3008881809-2026-00200
• Device Sequence Number: 9620534
• Product Code: DQY
• UDI-Device Identifier: 04546540698155
• UDI-Public: (01)04546540698155(17)271121(10)25295393
• 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): 04/07/2026

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: 25295393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2024
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER).; MACH 1 CATHETER (BOSTON SCIENTIFIC).; SURPASS EVOLVE STENT (STRYKER).
• Patient Sex: Male