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	04/10/2025
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, there was extensive evidence of deposits and roughness/damage to the hydrophilic coating to the distal 10-15cm of the subject guidewire.There was a fracture noted to the nitinol tubing and there was some evidence of swelling to the hydrated hydrophilic coating to the distal tip of the subject guidewire.A functional test was not performed due to the condition of the returned device.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 difficulty to advance the guidewire was not replicated, however the analysis results are consistent with the reported event.The device failed to meet specification when received, based on the damage noted to the device.It was reported that the physician prepared and flushed the subject guidewire as usual, then attempted to advance the microcatheter to the left vertebral artery (va).However, the subject guidewire encountered significant resistance during the superselective catheterization process, and the advancement within the microcatheter was very difficult.The physician first replaced the microcatheter with a new one, but still encountered difficulty in manipulating the guidewire, with high resistance to advancement.Additional information received indicates that continuous flush was set up and maintained throughout the clinical procedure and the patient's anatomy was moderately tortuous.The device was returned and there was damage/roughness noted to the distal end of the hydrophilic coating; this is indicative of high friction being experienced.There was a small fracture noted to the nitinol tubing.There was some slight swelling to the hydrophilic coating when hydrated.It is probable that the difficulty experienced in advancing the subject guidewire caused the damage to the distal coating and the fracture to the nitinol tubing.The anatomy was described as moderately tortuous; this is like to be the cause for the difficulty experienced to advance the subject guidewire.The hydration to the hydrophilic coating to the distal end is not likely to have caused or contributed to the reported events as the coating is intended to absorb water when hydrated to increase lubricity to aid in navigation, in doing so the coating expands, however this is compliant and should not affect the device functionality.Based on the review of all available information, an assignable cause of procedural factors will be assigned to the reported guidewire difficult to advance and to the analyzed guidewire broken/fractured during use, guidewire hydrophilic coating surface rough and guidewire coating issue, 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 guidewire was returned for analysis, and it was discovered that the subject guidewire nitinol tubing was noted to be fractured.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 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: 22846996
• Report Number: 3012931345-2025-00137
• Device Sequence Number: 4419367
• Product Code: DQX
• UDI-Device Identifier: 04546540688781
• UDI-Public: (01)04546540688781(17)270312(10)0000633357
• 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
• Report Date (Section B): 08/20/2025

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: 0000633357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 08/20/2025
• 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: REBAR 18 MICROCATHETER (UNKNOWN)
• Patient Age: 57 YR
• Patient Sex: Unknown
• Patient Race: Asian