MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO2-14 SUPPORT STRAIGHT 215CM; GUIDE, WIRE, CATHETER, NEUROVASCULATURE

Catalog Number	S2SPS14215
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection the guidewire was returned in 2 fragments (approximately 5cm and 210cm) held together by the core wire.The core wire was not broken but was stretched.The distal tip of the guidewire appeared to have been shaped.The distal fragment was inspected.The nitinol tubing on the guidewire distal end was broken/fractured approximately 5cm from the distal end.The nitinol tubing surface was rough.The core wire distal end was observed through the distal tip dome.The proximal fragment was inspected.The nitinol tubing on the guidewire proximal end was noted to be broken/fractured approximately 210cm from the proximal end.The nitinol tubing surface was rough.A functional inspection was not required.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 event was confirmed based on the damage noted to the returned device.The device failed to meet specification when returned for analysis.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.Analysis of the returned device found the synchro 2-14 guidewire was returned in 2 fragments (approximately 5cm and 210cm) held together by the core wire.The core wire was not broken but was stretched.An attempt appeared to have made to shape the guidewire.The broken nitinol tubing surface on both the distal and proximal fragments was rough which indicates a force was applied during the procedure that caused the guidewire to break and the core wire to become stretched.An assignable cause of procedural factors will be assigned to the as reported ¿guidewire distal tip stretched¿ and ¿guidewire difficult to advance¿ and as analyzed ¿guidewire distal tip broken/fractured during use¿ and ¿guidewire distal tip stretched¿ 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
The guidewire subject device was returned for analysis and it was discovered that the subject guidewire distal tip was broken/fractured during use.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: SYNCHRO2-14 SUPPORT STRAIGHT 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: 21433259
• Report Number: 3012931345-2025-00041
• Device Sequence Number: 11916674
• Product Code: MOF
• UDI-Device Identifier: 07613327459630
• UDI-Public: (01)07613327459630(17)261211(10)0000597623
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K190843
• 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
• Report Date (Section B): 02/21/2025

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: S2SPS14215
• Device Lot Number: 0000597623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2023
• 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
• Patient Sex: Unknown
• Patient Race: Asian