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	08/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Analysis of the returned device found that the subject guidewire distal tip was broken/fractured during use.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully.
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During the visual inspection, the subject guidewire was seen to be fractured along the nitinol tubing with the platinum wire stretched.The core wire could not be seen.The distal tip was seen to be kinked.The functional inspection was unable to perform.The as reported codes 'guidewire friction' and 'guidewire distal tip stretched' were confirmed during analysis.The device failed to meet 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.It was reported that during the procedure, the subject guidewire encountered difficulty in super selection at the m1 segment and could not be advanced to the target location.The physician withdrew the subject guidewire and observed stretching at its tip.Subsequently, another guidewire of the same catalog was used, allowing successful super selection, and the procedure was completed successfully.Additional information provided by the customer indicated that the device was prepared for use as per the directions for use (dfu), the device was confirmed to be in good condition during preparation/prior to use on the patient and continuous flush was set up and maintained throughout the clinical procedure.The patient's anatomy was severely tortuous.The subject guidewire was returned, and it was confirmed that the distal end of the subject guidewire had been severely kinked and stretched and the nitinol tubing was broken/fractured.It is probable that the tortuous nature of the patient's anatomy may have posed some challenged during the attempt to advance the subject guidewire to the lesion, subsequently causing the subject guidewire distal end to become damaged as seen in the analysis of the returned device.An assignable cause of procedural factors will be assigned to the reported defects 'guidewire friction', 'guidewire distal tip stretched' and to the as analyzed defects 'guidewire distal tip stretched', 'guidewire distal end/tip broken fractured during use' and 'guidewire distal tip kinked/bent', as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the directions for use (dfu) but due to procedural and/or anatomical factors during use, the product performance was limited.

• 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: 23721375
• Report Number: 3012931345-2025-00191
• Device Sequence Number: 18758114
• Product Code: MOF
• UDI-Device Identifier: 07613327508499
• UDI-Public: (01)07613327508499(17)280414(10)0000818186
• 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
• Report Date (Section B): 12/04/2025

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: SSTD215STR
• Device Lot Number: 0000818186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2025
• 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: SL-10 MICROCATHETER (STRYKER)
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Race: Asian