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	12/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the microcatheter (subject device) associated with the stent for assisted coil embolization of an aneurysm at the ophthalmic artery segment.After normal hydration of the subject device, under the guidance of a guidewire, the physician attempted to deliver the subject device to the horizontal segment of the middle cerebral artery (mca).When subsequently advancing it with normal force to the cavernous sinus segment, the yellow buffer zone at the proximal end of the subject device ruptured.The physician then withdrew the subject device out of the body, selected another microcatheter, successfully delivered it to the target location, and smoothly deployed the stent.Finally, after passing coils through the stent mesh and filling three coils, the procedure was concluded without any clinical consequences to the patient.
Event or Problem Description
It was reported that the microcatheter (subject device) associated with the stent for assisted coil embolization of an aneurysm at the ophthalmic artery segment.After normal hydration of the subject device, under the guidance of a guidewire, the physician attempted to deliver the subject device to the horizontal segment of the middle cerebral artery (mca).When subsequently advancing it with normal force to the cavernous sinus segment, the yellow buffer zone at the proximal end of the subject device ruptured.The physician then withdrew the subject device out of the body, selected another microcatheter, successfully delivered it to the target location, and smoothly deployed the stent.Finally, after passing coils through the stent mesh and filling three coils, the procedure was concluded without any clinical consequences to the patient.
Additional Manufacturer Narrative
D4 expiration date ¿ added.D4 gtin- added.D9 product available to stryker / returned to manufacturer on ¿ updated.H3 device evaluated by mfg ¿updated.H4 manufacturing date ¿ added.Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual/microscopic inspections was performed as the catheter shaft of the subject microcatheter device was noted to be broken/fractured under the strain relief.The catheter inner coil was noted to be damaged.The catheter shaft was noted to be flat/crushed and kinked/bent.The catheter was noted to be blocked/occluded.A functional inspection could not be performed due to the condition of the returned subject device.The reported defect was confirmed based on analysis of the subject device.The subject device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the subject device.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.Additional information provided by the customer indicated that the subject 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 subject microcatheter 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.It was reported that the physician attempted to deliver the subject microcatheter to the horizontal segment of the middle cerebral artery (mca).When subsequently advancing it with normal force to the cavernous sinus segment, the yellow buffer zone at the proximal end of the microcatheter ruptured.After removing the subject microcatheter, the operator found the fractured section of it was stretched.During analysis, the subject catheter shaft was noted to be broken/fractured under the strain relief.The catheter inner coil was noted to be damaged.The subject catheter shaft was noted to be kinked/bent and flat/crushed.The subject catheter was noted to be blocked/occluded.Based on a review of all available information and the analysis of the returned subject device it is probable the subject catheter shaft was damaged during manipulation of the subject device during the procedure.An assignable cause of procedural factors will be assigned to the as reported and as analyzed 'catheter shaft broken/fractured during use', and ' catheter shaft stretched' as well as the as analyzed ('catheter shaft damaged', ' catheter shaft kinked/bent', ' catheter shaft flat/crushed' and 'catheter shaft blocked/occluded') 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.

• 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: 23874121
• Report Number: 3008881809-2025-00744
• Device Sequence Number: 5546677
• Product Code: DQY
• UDI-Device Identifier: 04546540698131
• UDI-Public: (01)04546540698131(17)280809(10)25770384
• 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): 04/06/2026

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: M003XT2750810
• Device Lot Number: 25770384
• 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: 12/18/2025
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2025
• 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: EZ STENT (STRYKER); SYNCHRO2 GUIDEWIRE (STRYKER)
• Patient Age: 63 YR
• Patient Sex: Unknown
• Patient Race: Asian