MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO2-14 STANDARD STRAIGHT 300CM; WIRE, GUIDE, CATHETER

Catalog Number	M00326510
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is 2 of 2 reports (2nd mdr).
Event or Problem Description
It was reported that the guidewire (subject device) was used as a replacement device for the initially used guidewire.However, the subject device could not cross the lesion.After a while of continuous attempts, the fluoroscopy revealed a fracture on the subject device.The physician withdrew the subject device and found the distal tip to be fractured 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 the guidewire (subject device) was used as a replacement device for the initially used guidewire.However, the subject device could not cross the lesion.After a while of continuous attempts, the fluoroscopy revealed a fracture on the subject device.The physician withdrew the subject device and found the distal tip to be fractured 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
This is 2 of 2 reports (2nd mdr).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, it was noted that the guidewire was returned in 2 fragments (approximately 9.1 cm and 290.8 cm).The distal fragment was inspected and the guidewire appeared to have been shaped and was kinked/bent towards the distal end.The nitinol tubing on the guidewire distal end was broken/fractured approximately 9.1cm from the distal end.The core wire was broken/fractured and the platinum coil was severely stretched and broken/fractured.The nitinol tubing surface was rough and presence of crystallized procedural fluid was evident.The core wire distal end was observed through the distal tip dome.The proximal fragment was inspected and the nitinol tubing on the guidewire proximal end was noted to be broken/fractured approximately 290.8cm.The core wire was broken/fractured and the platinum coil was severely stretched and broken/fractured.The surface of the broken core wire was rough and crystallized procedural fluid was present around the platinum coil.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 specification when received for complaint investigation based on the analyzed anomalies noted to the device.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.There was no indication of a user related issue.The anatomy was reported to be moderately tortuous.Other devices used in the procedure in conjunction with the subject device was a microcatheter.The guidewire was swapped and reused during the procedure by soaking the guide wire in physiological saline every time it is used up.The guidewire tip was not shaped.The wire was torqued to overcome the resistance.There was no surgical delay reported due to the event.The distal tip of the guidewire was fractured and stretched.The statement ¿with the outer layer fractured¿ was clarified to mean, the tip of the guide wire is composed of a core wire and an outer nickel titanium hypotube structure.The core wire did not break, but the outer hypotube structure broke.The guidewire was positioned in the v4 segment of vertebral artery when the issue occurred.It is probable that the damage to the returned guidewire indicates the device encountered a significant force during use to have caused this damage.This force most likely occurred while adjusting the guidewire's direction multiple times during the procedure in addition to swapping and reusing the guidewire during the procedure.Based on the review of all available information, an assignable cause of procedural factors will be assigned to the as reported 'guidewire friction¿, 'guidewire distal tip broken/fractured during use' and 'guidewire distal tip stretched' and as analysed 'guidewire distal tip broken/fractured during use', 'guidewire distal tip stretched' and 'guidewire kinked/bent¿ 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: SYNCHRO2-14 STANDARD STRAIGHT 300CM
• Common Device Name: WIRE, GUIDE, CATHETER
• 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: 22181350
• Report Number: 3012931345-2025-00102
• Device Sequence Number: 12862407
• Product Code: DQX
• UDI-Device Identifier: 04546540688781
• UDI-Public: (01)04546540688781(17)270312(10)0000633365
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K053268
• 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): 06/30/2025

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: M00326510
• Device Lot Number: 0000633365
• 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: 05/24/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2024
• 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: HEADWAY 17 MICROCATHETER (NON-STRYKER)
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Race: Asian