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	03/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure there was resistance felt when manipulating the subject guidewire (wasn¿t moving smoothly), and just as stent was advanced close to lesion the subject guidewire became stuck.Upon attempting to remove the subject guidewire, more resistance was felt until the subject guidewire felt like it ¿broke free¿ of whatever was causing the resistance.When the subject guidewire was removed from the patient, it was observed to be ¿fractured and stretched¿ at the distal end.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during procedure, there was resistance felt when manipulating the subject guidewire (wasn¿t moving smoothly), and just as stent was advanced close to lesion the subject guidewire became stuck.Upon attempting to remove the subject guidewire, more resistance was felt until the subject guidewire felt like it ¿broke free¿ of whatever was causing the resistance.When the subject guidewire was removed from the patient, it was observed to be ¿fractured and stretched¿ at the distal end.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual testing as well as functional testing cannot be performed.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.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.It was reported that there was resistance felt when manipulating the wire (wasn¿t moving smoothly), and just as stent was advanced close to lesion the wire became ¿stuck¿.Upon attempting to remove the wire, more resistance was felt until the wire felt like it ¿broke free¿ of whatever was causing the resistance.When the wire was removed from the patient, it was observed to be ¿fractured and stretched¿ at the distal end.Additional information received indicated that the wire was torqued to overcome the resistance and normal force was used to overcome resistance.It is probable that there may have been anatomical and/or procedural factors present during use of the device causing the reported resistance, it is probable that the device was then fractured and stretched as a result of torquing and advancing against force during removal of the guidewire.An assignable cause of procedural factors will be assigned to the reported guidewire distal end/tip broken/fractured during use, guidewire distal tip stretched and guidewire does not have smooth movement, 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.

• 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: 21816441
• Report Number: 3012931345-2025-00075
• Device Sequence Number: 12654561
• Product Code: MOF
• UDI-Device Identifier: 07613327459630
• UDI-Public: (01)07613327459630(17)280103(10)0000773102
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 06/25/2025

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: 0000773102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 04/10/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/04/2025
• 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
• Patient Age: 53 YR
• Patient Sex: Female