MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR 1018 STRAIGHT 2 TIP 150CM; CATHETER, CONTINUOUS FLUSH

Catalog Number	M0031441890
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	06/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during endovascular coiling procedure as the 4th detachable coil was attempted but during deployment, the microcatheter¿s tip (subject device) herniated out of the aneurysm neck.Multiple unsuccessful attempts were made unsuccessfully to pass the previous placed stent and advance the subject microcatheter into the ventral portion of the aneurysm dome which resulted in an extended duration of procedure and radiation exposure.The coil was retrieved without detachment.The subject device was exchanged for another microcatheter to complete the procedure without any clinical consequences to the patient.
Additional Manufacturer Narrative
D4 gtin- added due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.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 during implantation of the 4th coil, the subject microcatheter tip herniated out of the aneurysm, which led to an exchange of the microcatheter.Subsequently, there were multiple unsuccessful attempts to implant the 4th coil, resulting in a longer procedure duration, increased radiation exposure, and ultimately alopecia due to radiation exposure.While there are a number of potential causes for the reported issues, because the product was not returned, review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned.This is 1 of 2 mdr reports.
Additional Manufacturer Narrative
This is 1 of 2 reports.
Event or Problem Description
It was reported that during endovascular coiling procedure as the 4th detachable coil was attempted but during deployment, the microcatheter¿s tip (subject device) herniated out of the aneurysm neck.Multiple unsuccessful attempts were made unsuccessfully to pass the previous placed stent and advance the subject microcatheter into the ventral portion of the aneurysm dome which resulted in an extended duration of procedure and radiation exposure.The coil was retrieved without detachment.The subject device was exchanged for another microcatheter to complete the procedure without any clinical consequences to the patient.

• Brand Name: EXCELSIOR 1018 STRAIGHT 2 TIP 150CM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• 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: 23838584
• Report Number: 3008881809-2025-00734
• Device Sequence Number: 9607419
• Product Code: KRA
• UDI-Device Identifier: 04546540688125
• UDI-Public: (01)04546540688125(17)280219(10)25454716
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K994155
• 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): 02/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: M0031441890
• Device Lot Number: 25454716
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2025
• 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: HEADWAY 17 MICROCATHETER.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White