MAUDE Adverse Event Report: Stryker Neurovascular-Utah-Salt Lake City SYNCHRO SELECT-14 SUPPORT ST 215CM; Guide, Wire, Catheter, Neurovasculature

Catalog Number	SSUP215STR
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during the thrombectomy procedure while advancing the subject guidewire, and resistance was encountered intravascularly.The distal tip fractured on the guidewire.The detached fragment and thrombus were retrieved using a stent retriever and aspiration catheter.The procedure was completed with no clinical consequences to the patient.

• Brand Name: SYNCHRO SELECT-14 SUPPORT 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 ; +1(510)413-2500
• MDR Report Key: 50465740
• Report Number: 3012931345-2026-00134
• Device Sequence Number: 9982200
• Product Code: MOF
• UDI-Device Identifier: 07613327508611
• UDI-Public: (01)07613327508611(17)290323(10)0001362455
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K202522
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: SSUP215STR
• Device Lot Number: 0001362455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/10/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2026
• 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: Aspiration Catheter (Unknown).; Balloon guide catheter (Unknown).; Trevo stent retriever (Stryker).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown