MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO2-14 SUPPORT PRE-SHAPED 300CM; GUIDE, WIRE, CATHETER, NEUROVASCULATURE

Catalog Number	S2SPP14300
Medical Device Problem Codes	Fracture (1260); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the poly tetra fluoro ethylene (ptfe) coating along the guidewire was seen to be peeling at roughly 133cm.The guidewire was fractured with the platinum wire stretched and core wire exposed.A functional inspection was unable to be performed due to damage.The reported event of 'guidewire difficulty to advance' could not be replicated; however, the analysis results are consistent with the reported event.The reported event of 'guidewire distal tip damaged' was confirmed during analysis.The reported event of 'guidewire distal tip stretched' was confirmed during analysis.The device met 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, after delivering the microcatheter to the target site using a guidewire, the physician withdrew the guidewire and replaced it with subject guidewire.After wetting the guidewire on the table, the physician began advancing it.When advancing it to the proximal end of the microcatheter, the physician noticed that the subject guidewire's advancement within the microcatheter was sluggish and difficult.Consequently, the physician withdrew the subject guidewire and replaced it with a new one.It is probable lack of hydration and/or the patients anatomy contributed to the defect.The subject guidewire was returned, the guidewire distal end was seen to be fractured along the nitinol tubing with the platinum wire stretched.The guidewire ptfe coating was noted to be peeling.This could have been upon removal of the torque device.Based on review of all available information an assignable cause of procedural factors will be assigned to the reported event of 'guidewire difficult to advance' as these defects appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.An assignable cause of procedural factors will be assigned to the reported and analysed events of 'guidewire distal tip damaged', 'guidewire distal tip stretched' and analysed event of 'guidewire distal tip broken/fractured during use' as these defects appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.An assignable cause of 'handling damage' will be assigned to the analysed event of 'guidewire ptfe coating peeling' as the defect appears to be associated with handling of the product or portion of the product during preparation.
Event or Problem Description
The guidewire (subject device) was returned for analysis and observed that the distal tip of the subject device was damaged, stretched and broken/fractured during use.Also, the ploy tetra fluoro ethylene (ptfe) coating of the subject device was peeling.The subject device was reported to be replaced, and the procedure was reported to completed successfully.No clinical consequences were reported to the patient.

• Brand Name: SYNCHRO2-14 SUPPORT PRE-SHAPED 300CM
• 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: 24792780
• Report Number: 3012931345-2026-00069
• Device Sequence Number: 8805808
• Product Code: MOF
• UDI-Device Identifier: 07613327459661
• UDI-Public: (01)07613327459661(17)271107(10)0000747842
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 04/06/2026

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: S2SPP14300
• Device Lot Number: 0000747842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR SL-10 MICROCATHETER (STRYKER)
• Patient Sex: Unknown
• Patient Race: Asian