MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO SELECT-14 SOFT ST 215CM; GUIDE, WIRE, CATHETER, NEUROVASCULATURE

Catalog Number	SSFT215STR
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the percutaneous intracranial arterial thrombectomy procedure the physician noticed the coating peeling off on the subject guidewire.A tomography imaging (ct scan) was performed and revealed metallic artifacts.The procedure was completed using the same guidewire successfully.There were no clinical consequences to the patient due to this event.
Event or Problem Description
It was reported that during the percutaneous intracranial arterial thrombectomy procedure the physician noticed the coating peeling off on the subject guidewire.A tomography imaging (ct scan) was performed and revealed metallic artifacts.The procedure was completed using the same guidewire successfully.There were no clinical consequences 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.Visual and functional inspections were not conducted due to 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.The reported ¿guidewire ptfe coating peeling¿ was unable to be confirmed and it cannot be confirmed that the device met specification, as the device was not returned.As per the additional information, the device was prepared for use as per the directions for use, the device was confirmed to be in good condition during preparation/prior to use on the patient, continuous flush was set up and maintained throughout the clinical procedure and the patient¿s anatomy was moderately tortuous.Peeling to the polytetrafluoroethylene (ptfe) coating can occur due to interaction with an under tightened torque device causing it to scrape the ptfe coating causing damage.Backloading of the guidewire through the supplied introducer has been known to cause skiving of the ptfe coating.As the device was not returned and a review of all available information fails to indicate an assignable cause for the reported pfte coating peeling, an assignable cause of undeterminable will be assigned to the reported event: ¿guidewire ptfe coating peeling¿.
Additional Manufacturer Narrative
B5 executive summary: updated.There are controls in the manufacturing process to ensure the product met specifications upon release.Visual and functional inspections were not conducted due to the device was not returned.The reported guidewire ptfe coating peeling 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 during a percutaneous intracranial arterial thrombectomy procedure, the physician noticed coating peeling off on the synchro select guidewire being used during the thrombectomy maneuver.Dnlyct imaging revealed metallic artifacts.As per the additional information, the device was prepared for use as per the directions for use, the device was confirmed to be in good condition during preparation/prior to use on the patient, continuous flush was set up and maintained throughout the clinical procedure and the patients anatomy was moderately tortuous.Peeling to the ptfe (polytetrafluoroethylene) coating can occur due to interaction with an undertightened torque device causing it to scrape the ptfe coating causing damage.Backloading of the guidewire through the supplied introducer has been known to cause skiving of the ptfe coating.Itt cannot be definitively determined if the ptfe peeling was related to the abnormal imaging finding.As the device was not returned and a review of all available information fails to indicate an assignable cause for the reported pfte coating peeling, an assignable cause of undeterminable will be assigned to the reported 'guidewire ptfe coating peeling' and 'patient abnormal image finding'.
Event or Problem Description
It was reported that during the percutaneous intracranial arterial thrombectomy procedure the physician noticed the coating peeling off on the subject guidewire.A tomography imaging (ct scan) was performed and revealed metallic artifacts.The procedure was completed using the same guidewire successfully.There were no clinical consequences to the patient due to this event.Updated: based on the information from hospital, the dnlyct only indicates the presence of metal artifacts, suggesting a possibility of coating left inside patient¿s vessel, but there was no direct evidence to confirm this has occurred within the patient's vessels.Subsequently, the patient did not experience any vessel occlusion or stenosis.

• Brand Name: SYNCHRO SELECT-14 SOFT ST 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: 23457432
• Report Number: 3012931345-2025-00176
• Device Sequence Number: 18134897
• Product Code: MOF
• UDI-Device Identifier: 07613327508574
• UDI-Public: (01)07613327508574(17)270916(10)0000723929
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K202522
• 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): 02/19/2026

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: SSFT215STR
• Device Lot Number: 0000723929
• 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: 10/13/2025
• Supplement Date Received by Manufacturer: 12/10/2025; 01/28/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/18/2025; 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2024
• 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
• Patient Race: Asian