MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 STRAIGHT 2 TIP 150CM; CATHETER, PERCUTANEOUS

Catalog Number	M0031681890
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is 2 of 2 reports (2nd mdr).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 subject microcatheter was received with a stent partially deployed from the distal end of the microcatheter.The stent was noted to be protruding through a hole at the distal end of the subject microcatheter.The sdw was able to be removed from the subject microcatheter.The stent was unable to be removed from the microcatheter.The microcatheter shaft was unable to be flushed.During functional inspection a 0.023" pin gauge was verified to meet the catheter shaft when inserted into the catheter hub.A 0.0158" patency mandrel was able to be advanced through the microcatheter, resistance was noted.The reported event of 'catheter shaft friction' 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.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 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.It was reported that when one-third of the stent had been deployed, the physician found that the stent was stuck at the tip of the subject microcatheter.When attempting to continue deployment, there was significant resistance.Therefore, the physician had to advance an intermediate catheter distally and carefully retract the partially deployed stent back into the intermediate catheter, and then withdrew them together out of the body.During analysis, the subject microcatheter was received with a stent partially deployed from the distal end of the microcatheter.The stent was noted to be protruding through a hole at the distal tip of the microcatheter.The sdw was able to be removed from the microcatheter.The stent was unable to be removed from the microcatheter.The microcatheter shaft was unable to be flushed.A 0.023" pin gauge was verified to meet the catheter shaft when inserted into the catheter hub.A 0.0158" patency mandrel was able to be advanced through the microcatheter, resistance was noted.Based on a review of all available information and the analysis of the returned device it is probable that due to the friction experienced, the stent was advanced with force causing the struts of the stent to protrude though the catheter shaft.An assignable cause of procedural factors will be assigned to the reported and analysed event of 'catheter shaft friction' as well as the analysed event of 'device difficult to flush' and 'catheter shaft has hole/perforation' 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
The catheter (subject device) was returned for analysis and it was discovered that the distal shaft of catheter has a hole/perforation.The catheter was difficult to flush and resistance was noted within the shaft of catheter.The subject device was reported to be replaced and procedure was reported to be completed successfully.No clinical consequences were reported to the patient.

• Brand Name: EXCELSIOR SL-10 STRAIGHT 2 TIP 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: 24710232
• Report Number: 3008881809-2026-00174
• Device Sequence Number: 17562106
• Product Code: DQY
• UDI-Device Identifier: 04546540688217
• UDI-Public: (01)04546540688217(17)270415(10)25552172
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K013789
• 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): 03/27/2026

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: M0031681890
• Device Lot Number: 25552172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2025
• 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: NEUROFORM ATLAS STENT (STRYKER)
• Patient Sex: Unknown
• Patient Race: Asian