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	01/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure for a middle cerebral artery aneurysm, due to the extremely tortuous nature of the patient's vessels, the physician needed to repeatedly twist and manipulate the subject guidewire for adjustments.During the super selection process, it was discovered that the subject guidewire had fractured approximately 10 cm from its tip, with half remaining inside the vessel and the other half inside the microcatheter.The physician immediately advanced an intermediate catheter to cover the microcatheter, closed the drip infusion, and used a syringe to aspirate.Subsequently, the microcatheter was withdrawn from the body, and the guidewire was removed.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were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
D4- expiration date- updated, d4- gtin- updated, d9 - product available to stryker - updated, d9 - returned to manufacturer on - updated, h3 - device evaluated by mfg ¿ updated, h4- manufacturing date- 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 visual inspection the guidewire was returned in two fragments.The guidewire was kinked in two locations along the mid-section.The guidewire had a rigid fracture along the nitinol tubing where the core and platinum wire were exposed and fractured at 207cm (prox) and 8.2cm (distal).The functional inspection was not applicable (n/a).The reported event ¿guidewire distal tip broken/fractured during use¿ was confirmed during analysis.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 while super selectively advancing into the upper trunk of the parent artery, due to the extremely tortuous nature of the patient's vessels, the physician needed to repeatedly twist and manipulate the guidewire for adjustments.During the super selection process, it was discovered that the guidewire had fractured approximately 10 cm from its tip, with half remaining inside the vessel and the other half inside the microcatheter.The physician immediately advanced an intermediate catheter to cover the microcatheter, closed the drip infusion, and used a syringe to aspirate.Subsequently, the microcatheter was withdrawn from the body, and the guidewire was removed.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient, continuous flush set up and maintained throughout the clinical procedure, the patient's anatomy was severely tortuous.The device was returned and it was confirmed that the distal end of the guidewire had been fractured confirming the reported event.It is probable that the guidewire was fractured as it was repeatedly twisted and manipulated for adjustments through the severely tortuous anatomy.An assignable cause of procedural factors will be assigned to the reported event ¿guidewire distal tip broken/fractured during use¿ and the analysed events ¿guidewire distal tip broken/fractured during use¿ and ¿guidewire mid section kinked/bent¿, as these defects appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.
Event or Problem Description
It was reported that during a procedure for a middle cerebral artery aneurysm, due to the extremely tortuous nature of the patient's vessels, the physician needed to repeatedly twist and manipulate the subject guidewire for adjustments.During the super selection process, it was discovered that the subject guidewire had fractured approximately 10 cm from its tip, with half remaining inside the vessel and the other half inside the microcatheter.The physician immediately advanced an intermediate catheter to cover the microcatheter, closed the drip infusion, and used a syringe to aspirate.Subsequently, the microcatheter was withdrawn from the body, and the guidewire was removed.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• 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: 24316217
• Report Number: 3012931345-2026-00029
• Device Sequence Number: 5676283
• Product Code: MOF
• UDI-Device Identifier: 07613327508499
• UDI-Public: (01)07613327508499(17)280517(10)0000833628
• 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): 03/24/2026

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: 0000833628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Race: Asian