MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO-14 STRAIGHT 200-35CM; WIRE, GUIDE, CATHETER

Catalog Number	M00313010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure at the left internal carotid artery (ica) aneurysm, the subject guidewire broke.Additional information received on (b)(6) 2025 states that the patient had a direct bleed during the procedure.No additional information is available.
Additional Manufacturer Narrative
Section c2/d10 concomitant products grid - added.Section b1 adverse event/product problem - corrected - no adverse event and product problem only product problem.Section b5 executive summary - updated.Section h1 type of reportable event - corrected from serious injury to malfunction.Section f10 / h6 clinical signs code grid - health effect - clinical code - updated.Section f10 / h6 health impact code grid - health effect - impact code - updated.
Event or Problem Description
It was reported that during procedure at the left internal carotid artery (ica) aneurysm, the subject guidewire broke.Additional information received on (b)(6) 2025 states that the patient had a direct bleed during the procedure.No additional information is available.Update: it was reported that during a procedure at the left internal carotid artery (ica) aneurysm, the distal of the subject guidewire broke.The subject guidewire tip detached from the remainder of the guidewire while attempting to cross the giant aneurysm using torque.Additional information received on 12-may-2025 indicated that the adverse event was not related to the subject guidewire.The physician noted: ¿the aneurysm size was large, and these cases carry a high risk of rupture.¿ the procedure was successfully completed the following day using a stent and coiling.No further information is available.
Additional Manufacturer Narrative
Based on the results of the dhr (device history record) review, there is no indication that the subject device, labeling or packaging failed to meet its specifications when released.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported event cannot be confirmed, and it cannot be confirmed that the subject device met specification, as the subject device 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.It was reported that the patient had a direct bleed during the procedure.The procedure was successfully completed two days later.The physician believes the incident occurred due to extreme tortuosity with excessive torque being applied to the subject device during the navigation in order to get distal entry into the normal vessel to deploy the flow diverter stent.Additional information received identified that the patient¿s anatomy was severely tortuous and this most likely contributed to the reported event.It is most likely that the subject device experienced difficulties during navigation through the patients tortuous anatomy, which may have led to difficulties while torqueing the subject device and subsequent the subject device fractured.An assignable cause of procedural factors will be assigned to the reported event, 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 procedure at the left internal carotid artery (ica) aneurysm, the subject guidewire broke.Additional information received on 16-apr-2025 states that the patient had a direct bleed during the procedure.No additional information is available.Update: it was reported that during a procedure at the left internal carotid artery (ica) aneurysm, the distal of the subject guidewire broke.The subject guidewire tip detached from the remainder of the guidewire while attempting to cross the giant aneurysm using torque.Additional information received on 12-may-2025 indicated that the adverse event was not related to the subject guidewire.The physician noted: ¿the aneurysm size was large, and these cases carry a high risk of rupture.¿ the procedure was successfully completed the following day using a stent and coiling.No further information is available.

• Brand Name: SYNCHRO-14 STRAIGHT 200-35CM
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer (Section G): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 21875313
• Report Number: 3012931345-2025-00082
• Device Sequence Number: 15645525
• Product Code: DQX
• UDI-Device Identifier: 07613252186922
• UDI-Public: (01)07613252186922(17)251111(10)0000585058
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K002907
• 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,Followup
• Report Date (Section B): 07/22/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/11/2025
• Device Catalogue Number: M00313010
• Device Lot Number: 0000585058
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: 05/12/2025; 07/10/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 06/03/2025; 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2023
• 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: PHENOM 27 MICROCATHETER (NON-STRYKER).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown