MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO SELECT-14 STANDARD ST 300CM; GUIDE, WIRE, CATHETER, NEUROVASCULATURE

Catalog Number	SSTD300STR
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure the physician selected the subject guidewire to establish access.During the super-selective procedure, the physician suspected that the subject guidewire had fractured.The subject guidewire was withdrawn from the body for inspection, and it was confirmed that the subject guidewire tip had broken and stretched.The subject device was replaced, and the procedure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 the procedure the physician selected the subject guidewire to establish access.During the super-selective procedure, the physician suspected that the subject guidewire had fractured.The subject guidewire was withdrawn from the body for inspection, and it was confirmed that the subject guidewire tip had broken and stretched.The subject device was replaced, and the procedure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
D9 product available to stryker: updated.D9 returned to manufacturer on: updated.H3 device evaluated by mfg: updated.C2/d10 concomitant products grid: updated.There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, approximately 292cm of the subject guidewire was returned.The guidewire was seen to be kinked/bent.The nitinol tubing, core wire and platinum coil were broken/fractured.The platinum coil was stretched and knotted around the core wire as per photos.Approximately 8 cm of the distal fragment was not returned.The functional inspection was not performed as the damage was confirmed during visual analysis.The reported event is covered in the device direction 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 event was confirmed based on the damage noted to the returned device.The device failed to meet specifications when returned for analysis.It was reported that ¿during the super-selective procedure, the physician suspected that the wire had fractured.The wire was withdrawn from the body for inspection, and it was confirmed that the wire had broken and stretched¿.Additional information provided by the customer did not indicate any issues noted during unpacking or set up of the device, and the device was prepared as per dfu instructions.The dispenser hoop was flushed before removing the guidewire.There was no indication of a user related issue.The anatomy was reported to be moderately tortuous.A microcatheter was used in the procedure and was used to finish the procedure.The guidewire tip was shaped 90 degrees.The issue was noted on the tip of the guidewire.The wire was not torqued to overcome the resistance, and no force was used to overcome resistance.No other difficulties were encountered during the usage of the device that could have contributed to the issue.The guidewire was not completely fractured, so the operator withdrew it as a whole.Analysis of the returned device found approximately 292cm of the subject guidewire was returned.Approximately 8cm of the distal fragment was not returned.The guidewire was be kinked/bent.The guidewire nitinol tubing was broken/fractured 292cm from the proximal end, with the platinum coil and core wire exposed and broken/fractured.The platinum coil was stretched and knotted around the core wire.The condition of the returned guidewire indicates a significant force was used during the procedure to have caused such damage.An assignable cause of procedural factors will be assigned to the as reported event ¿guidewire distal tip broken/fractured during use¿ and ¿guidewire distal tip stretched¿ and to the analyzed damage 'guidewire kinked/bent', ¿guidewire distal tip broken/fractured during use¿ and ¿guidewire distal tip stretched¿ and 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: SYNCHRO SELECT-14 STANDARD ST 300CM
• 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: 23813563
• Report Number: 3012931345-2025-00195
• Device Sequence Number: 9295109
• Product Code: MOF
• UDI-Device Identifier: 07613327508505
• UDI-Public: (01)07613327508505(17)280414(10)0000818152
• 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): 02/02/2026

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: SSTD300STR
• Device Lot Number: 0000818152
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 02/02/2026
• 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: ECHELON 10 MICROCATHETER (MEDTRONIC)
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Race: Asian