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	05/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the subject guidewire broke off during an intervention after probing during retraction.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
D4 expiration date: updated d4 gtin: 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 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.It was reported that the wire broke off during an intervention after probing during retraction.Additional information received indicates that continuous flush was set up and maintained throughout the clinical procedure and the patient¿s anatomy was moderately tortuous.The available information suggests the patient¿s anatomy was moderately tortuous, which may have contributed to the reported event, however this cannot be definitively determined.There are a number of potential causes for the reported event, however as the device was not returned and a review of all available information fails to indicate a probable assignable cause for the reported event, an assignable cause of undeterminable will be assigned to this complaint.
Event or Problem Description
It was reported that the subject guidewire broke off during an intervention after probing during retraction.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
D9 product available to stryker: updated.D9 returned to manufacturer on: updated.H3 device evaluated by mfg: updated.There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the subject guidewire was seen to be kinked.The polytetrafluoroethylene (ptfe) coating was seen to be peeling at 46cm.The subject guidewire was seen to be fractured along the nitinol tubing at 209.5cm with the platinum and core wire exposed and fractured, the distal end was not returned.The functional inspection was not performed as the reported damage was confirmed based on visual analysis.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.The reported guidewire broken/fractured during use was confirmed based on the analysis of the returned device.The device failed to meet specifications when returned or analysis.It was reported that the wire broke off during an intervention after probing during retraction.Additional information received indicates that continuous flush was set up and maintained throughout the clinical procedure and the patient¿s anatomy was moderately tortuous.The device was returned and it was confirmed that the guidewire was fractured, there was also kinking and peeling noted to the polytetrafluoroethylene (ptfe) coating.The available information suggests the patient¿s anatomy was moderately tortuous, which may have caused or contributed to the reported guidewire fracture.An assignable cause of procedural factors will be assigned to the reported and analysed guidewire broken/fractured during use and to the analysed guidewire kinked/bent, 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.The damage noted to the polytetrafluoroethylene (ptfe) coating is consistent with interaction with the torque device, which may have been under tightened during use or it may have been caused during removal of the torque device after use.An assignable cause of handling damage will be assigned to the analysed guidewire polytetrafluoroethylene (ptfe) coating peeling.
Event or Problem Description
It was reported that the subject guidewire broke off during an intervention after probing during retraction.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• 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: 22577110
• Report Number: 3012931345-2025-00119
• Device Sequence Number: 18506025
• Product Code: MOF
• UDI-Device Identifier: 07613327459630
• UDI-Public: (01)07613327459630(17)270701(10)0000688140
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K190843
• 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): 01/29/2026

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: S2SPS14215
• Device Lot Number: 0000688140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/14/2025
• Supplement Date Received by Manufacturer: 09/12/2025; 01/23/2026
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 09/18/2025; 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2024
• 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
• Patient Sex: Unknown