MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO SELECT-14 SOFT PS 215CM; GUIDE, WIRE, CATHETER, NEUROVASCULATURE

Catalog Number	SSFT215PRE
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during the procedure when the subject guidewire was removed to shape the distal tip, it was found to be fractured from mid to distal section.The device was replaced, and the procedure was completed successfully with no clinical consequences to the patient.
Additional Manufacturer Narrative
D9 - product available to stryker - updated.D9 - returned to manufacturer on ¿ updated.H3 device evaluated by mfg - updated.There are controls in the manufacturing process to ensure the product¿ met specifications upon release.During visual inspection, the guidewire was seen to be kinked/bent.The guidewire was seen to be broken/fractured approx.206 cm from the proximal end.The guidewire distal tip was seen to be kinked/bent.The core wire distal end was observed through the distal tip dome.The guidewire poly tetra fluoro ethylene (ptfe) was seen to be damaged approximately 40 cm from the proximal end.The functional inspection was not required as the event was confirmed during the visual inspection.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 complaint was confirmed based on 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 after advancing the microcatheter distal to the neck of the aneurysm and attempting access several times, the physician decided to remove the guidewire in order to shape the distal soft tip.It was reported that upon removal from the patient, the guidewire was found to be broken.Additional information provided by the customer indicated that the patient's anatomy was quite tortuous.There was no resistance encountered while removing the guidewire from the dispenser hoop.Continuous flush was maintained throughout the procedure.It is probable that the guidewire was fractured as it was torqued, possibly due to the tortuous anatomy.As per the instructions for use (ifu) " never advance, auger, withdraw, or torque a guidewire which meets resistance.Resistance may be felt and/or observed under fluoroscopy by noting any buckling or prolapse of the guidewire tip.Excessive force against resistance may result in damage to the guidewire, such as separation of the guidewire tip, damage to the interventional device, and/or vessel perforation.Determine the cause of the resistance under fluoroscopy and take any necessary remedial action".Based on the review of all available information, an assignable cause of procedural factors will be assigned to the reported and analysed ¿guidewire broken/fractured during use¿ as well analyzed ¿guidewire distal end/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 dfu but due to procedural and/or anatomical factors during use, the product performance was limited.It is probable that the proximal end of the guidewire was kinked as a result of handling of the device.The proximal ptfe coating damage is indicative of damage from the torque device, either due to an under tightened torque device or removal of the torque device after use.An assignable cause of handling damage will be assigned to the analysed ¿guidewire kinked/bent¿ and ¿guidewire ptfe coating peeling¿ as this complaint appears to be associated with handling of the product or portion of the product during the procedure.
Event or Problem Description
It was reported during the procedure when the subject guidewire was removed to shape the distal tip, it was found to be fractured from mid to distal section.The device was replaced, and the procedure was completed successfully with no clinical consequences to the patient.

• Brand Name: SYNCHRO SELECT-14 SOFT PS 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: 22025410
• Report Number: 3012931345-2025-00092
• Device Sequence Number: 21102602
• Product Code: MOF
• UDI-Device Identifier: 07613327508598
• UDI-Public: (01)07613327508598(17)270714(10)0000694110
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 06/24/2025

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: SSFT215PRE
• Device Lot Number: 0000694110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2024
• 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: EXCELSIOR XT-27 MICROCATHETER (STRYKER); SOFIA GUIDE CATHETER (NON-STRYKER)
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 70 KG