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

Catalog Number	S2SPS14300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection the guidewire was returned broken/fractured in in multiple segments, the segments were connected by stretched platinum wire.The core wire distal end was observed through the distal tip dome.A functional inspection could not be performed as the device was damaged.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.The event description states when the operator rotated the guidewire to pass the stenosis, tip of the guidewire was not moving when rotating the proximal of guidewire.The operator tried to withdraw the proximal of guidewire and the distal was not moved.Then locked the proximal of guidewire with the microcatheter to retract the system back into middle catheter and then withdrew the middle catheter out of patient's body to check and found tip of the guidewire was stretched.Analysis of the returned guidewire was returned broken/fractured in in multiple segments, the segments were connected by stretched platinum wire.The damage to the returned device indicates it encountered a significant force during use.An assignable cause of procedural factors will be assigned to the reported events: guidewire difficult remove/withdraw from catheter¿, ¿guidewire distal tip stretched¿, ¿guidewire torque problem¿ and analyzed events: ¿guidewire distal tip stretched¿ and ¿guidewire 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
The subject device was returned for analysis and the device investigation revealed that the guidewire 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 300CM
• 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: 21074243
• Report Number: 3012931345-2025-00002
• Device Sequence Number: 12858697
• Product Code: MOF
• UDI-Device Identifier: 07613327459647
• UDI-Public: (01)07613327459647(17)270312(10)0000633350
• 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): 01/03/2025

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: S2SPS14300
• Device Lot Number: 0000633350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 01/03/2025
• 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: ECHELON10 MICROCATHETER (NON-STRYKER).
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Race: Asian