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	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, 10cm distal tip of the subject guidewire separated from the body of the wire within the microcatheter.The distal tip and the wire were removed from the patient.The guidewire was replaced and the procedure was completed successfully with no clinical consequences to the patient.
Additional Manufacturer Narrative
H3 device evaluated by mfg ¿updated.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.During the visual inspection, approximately 204.6cm of the subject guidewire was returned.The distal fragment (approximately 10.4cm) was not returned.The nitinol tubing of the returned subject guidewire was broken/fractured, and the broken/fractured core wire and platinum coil were protruding from the nitinol with traces of procedural fluid evident.The nitinol tubing surface was rough.The core wire and platinum coil surfaces were also rough.The functional inspection was nor required.The reported complaint was confirmed based on analysis.The device failed to meet specification when received for complaint investigation based on the analyzed anomaly 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 ¿10cm distal tip of subject guidewire separated from the body of the wire within the microcatheter¿.Additional information provided by the customer indicated there was no damage noted to the packaging prior to preparation of the device and no anomalies noted to the device after removal from the packaging or prior to preparation.There was no resistance removing from hoop.The device was prepared as per the directions for use (dfu).Continuous flush maintained throughout the procedure.The device was confirmed to be in good condition prior to use.The patient¿s anatomy was not particularly tortuous.The guidewire was shaped with a gentle j.The wire was used in a non-stryker microcatheter.Navigating mma branches (not particularly tortuous branches).The same non-stryker microcatheter was used with a new wire.The procedure was completed.There were no adverse consequences reported for the patient as a result of the reported event.Analysis of the returned device found approximately 204.6cm of the subject guidewire was returned, however the distal fragment (approximately 10.4cm) was not returned.The nitinol tubing of the returned subject guidewire was broken/fractured, and the surface was rough.The core wire and platinum coil were protruding from the nitinol tubing and were also broken/fractured with traces of procedural fluid evident.The core wire and platinum coil surfaces were also rough.The damage to the returned subject guidewire indicates the device encountered a significant force during use.An assignable cause of procedural factors will be assigned to the as reported ¿guidewire distal tip broken/fractured during use¿ and as analyzed 'guidewire distal tip broken/fractured during use' 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.
Event or Problem Description
It was reported that during the procedure, 10cm distal tip of the subject guidewire separated from the body of the wire within the microcatheter.The distal tip and the wire were removed from the patient.The guidewire was replaced and the procedure was completed successfully with no clinical consequences to the patient.

• 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: 23126782
• Report Number: 3012931345-2025-00156
• Device Sequence Number: 15302258
• Product Code: MOF
• UDI-Device Identifier: 07613327508574
• UDI-Public: (01)07613327508574(17)280407(10)0000814537
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 11/04/2025

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: SSFT215STR
• Device Lot Number: 0000814537
• 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: 09/02/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2025
• 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: HEADWAY DUO 156CM. MICROCATHETER (UNKNOWN).
• Patient Sex: Unknown