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

Catalog Number	SSTD215STR
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure for an emergency embolization for a left middle cerebral artery bifurcation aneurysm, the physician selected a subject guidewire in conjunction with a microcatheter for the purpose of super-selecting the aneurysm.During the manipulation, the physician observed that the tip of the subject guidewire lost controllability within the microcatheter.Fluoroscopic examination revealed that approximately 10 centimeters of the radiopaque segment at the subject guidewire tip had fractured.While retracting the entire system, the fractured subject guidewire tip inadvertently fell into the patient's body.Ultimately, the physician successfully extracted the fractured guidewire using a stent retriever.The physician concluded the procedure immediately and the patient was transferred to a higher-level hospital to continue treatment.There is no additional information available.

• Brand Name: SYNCHRO SELECT-14 STANDARD 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: 24815817
• Report Number: 3012931345-2026-00072
• Device Sequence Number: 15874835
• Product Code: MOF
• UDI-Device Identifier: 07613327508499
• UDI-Public: (01)07613327508499(17)280819(10)0000951711
• 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
• Report Date (Section B): 07/01/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SSTD215STR
• Device Lot Number: 0000951711
• 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: 03/18/2026
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ECHELON 10 MICROCATHETER (MEDTRONIC); SOLITAIRE AB STENT (MEDTRONIC)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Race: Asian