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	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire (subject device) was used in the medical procedure.However, as the tip of the guidewire reached the v4 segment, with approximately 10 cm of the guidewire extending beyond the tip of the microcatheter, the physician found that the guidewire had broken at the distal end of the microcatheter and could not be manipulated.The physician promptly advanced the microcatheter forward and successfully withdrew the broken guidewire.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient.
Additional Manufacturer Narrative
H3 - device evaluated by mfg ¿ updated.There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection it was noted that the guidewire was returned in two fragments.The distal end of the guidewire was seen to be kinked.The poly tetra fluoro ethylene (ptfe) coating was seen to be peeling.The nitinol tubing was seen to be fractured with the core wire exposed.The core wire was observed through the distal tip dome.A functional evaluation was not required as the reported issue was confirmed visually.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.The reported event of 'guidewire distal tip broken/fractured during use' was confirmed during analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that 'as the tip of the guidewire reached the v4 segment, with approximately 10 cm of the guidewire extending beyond the tip of the microcatheter, the physician found that the guidewire had broken at the distal end of the microcatheter and could not be manipulated.' additional information provided by the customer indicated that the device was prepared for use as per the dfu.There was no damage noted to the packaging prior to opening the packaging.The device was confirmed to be in good condition during preparation/ prior to use on the patient.Continuous flush was set up and maintained throughout the clinical procedure.During analysis, the guidewire was returned in two fragments.The distal end of the guidewire was seen to be kinked.The ptfe coating was noted to be peeled.The nitinol tubing was seen to be fractured with the core wire exposed.Based on the characteristics of the ptfe peeling, it is probable that the observed condition may be consistent with interaction with the torque device, either during manipulation in use or during removal of the torque device.An assignable cause of handling damage will be assigned to the analysed events of 'guidewire ptfe coating peeling and guidewire distal end/tip kinked/bent' as this complaint appears to be associated with handling of the product or portion of the product during the procedure / upon removal of the product from the packaging / preparation of the product prior to use.It is probable that the guidewire fracture occurred as a result of repeated rotation or excessive manipulation during advancement.Additionally, anatomical factors such as vessel tortuosity may have contributed to increased stress on the guidewire during introduction, potentially leading to the observed damage.An assignable cause of procedural factors will be assigned to the reported and analysed events of '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 guidewire (subject device) was used in the medical procedure.However, as the tip of the guidewire reached the v4 segment, with approximately 10 cm of the guidewire extending beyond the tip of the microcatheter, the physician found that the guidewire had broken at the distal end of the microcatheter and could not be manipulated.The physician promptly advanced the microcatheter forward and successfully withdrew the broken guidewire.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient.

• 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: 24445549
• Report Number: 3012931345-2026-00039
• Device Sequence Number: 18717316
• Product Code: MOF
• UDI-Device Identifier: 07613327508499
• UDI-Public: (01)07613327508499(17)280617(10)0000848917
• 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): 03/19/2026

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: SSTD215STR
• Device Lot Number: 0000848917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ECHELON 10 MICROCATHETER (NON-STRYKER).
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Race: Asian