MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO2-14 SUPPORT STRAIGHT 215CM; GUIDE, WIRE, CATHETER, NEUROVASCULATURE

Catalog Number	S2SPS14215
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that physician found tip of subject guidewire stretched and at a certain point the subject guidewire appeared to no longer respond to torque control.The operator attempted to remove the guidewire to replace it, but it was broken and a portion remained inside the vessel.So, it was removed using a retriever and procedure was completed successfully.
Additional Manufacturer Narrative
D4 gtin: updated.D4 expiration date- updated.H4 manufacturing date ¿ updated.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 event was unable to be confirmed, and it cannot be confirmed that the device met specification, as the 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 physician observed a stretching at the distal part of the subject guidewire.The subject device was subsequently replaced with a new one.Additional information from the customer indicated that, at several point, the subject guidewire did not respond to torque control.It was also reported that upon removal of the subject guidewire, a portion of it remained inside the vessel.The retained part was successfully retrieved using an embotrap retriever.Based on a review of the available information, it is probable that the difficulty in torque response and the stretching of the subject guidewire were due to a fracture.There are a number of potential causes for a subject guidewire to fracture during use; however, because the device was not returned and the available information does not indicate an assignable cause for the reported event, the assignable cause for this complaint will be classified as undeterminable.
Event or Problem Description
It was reported that physician found tip of subject guidewire stretched and at a certain point the subject guidewire appeared to no longer respond to torque control.The operator attempted to remove the guidewire to replace it, but it was broken and a portion remained inside the vessel.So, it was removed using a retriever and procedure was completed successfully.

• Brand Name: SYNCHRO2-14 SUPPORT STRAIGHT 215CM
• Common Device Name: GUIDE, WIRE, CATHETER, NEUROVASCULATURE
• 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: 24361528
• Report Number: 3012931345-2026-00033
• Device Sequence Number: 11970997
• Product Code: MOF
• UDI-Device Identifier: 07613327459630
• UDI-Public: (01)07613327459630(17)280819(10)0000951605
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K190843
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: S2SPS14215
• Device Lot Number: 0000951605
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2025
• 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: EMBOTRAP (J&J MEDTECH CERENOVUS).
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown