MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO2-14 SOFT STRAIGHT 200CM; WIRE, GUIDE, CATHETER

Catalog Number	M00326010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
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 in 3 fragments (approximately 1.0cm was broken/fractured from the distal end, a 0.9cm distal fragment and 198.1cm was broken/fractured from the proximal end) held together by the platinum coil.The 2 distal fragments were inspected.The nitinol tubing on the guidewire distal end was broken/fractured approximately 1.0cm from the distal end with the platinum coil severely stretched and the core wire broken/fractured.The nitinol tubing on the 0.9cm distal fragment was also broken/fractured.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 198.1cm from the proximal end with the platinum coil severely stretched and the core wire broken/fractured.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 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 not tortuous.There was no resistance encountered removing the guidewire from the dispenser hoop.The guidewire tip was not shaped.Other associated devices used in the procedure were microcatheter and aspiration catheter.There was no friction/resistance encountered during the procedure.The guidewire was positioned within the middle carotid artery (mca) m1 when the issue occurred.There was no high tortuosity relative to the tip of the guidewire.The same microcatheter was not used to finish the procedure.There was no resistance between the guidewire and the microcatheter.No other difficulties were encountered during the usage of the device that could have contributed to the issue.Analysis of the returned device found the guidewire was returned in 3 fragments (approximately 1.0cm was broken/fractured from the distal end, a 0.9cm distal fragment and 198.1cm was broken/fractured from the proximal end) held together by the platinum coil.The nitinol tubing on the guidewire distal end was broken/fractured approximately 1.0cm from the distal end with the platinum coil severely stretched and the core wire broken/fractured.The nitinol tubing on the 0.9cm distal fragment was also broken/fractured.The nitinol tubing on the guidewire proximal end was noted to be broken/fractured approximately 198.1cm from the proximal end with the platinum coil severely stretched and the core wire broken/fractured.There was no damage noted to the device prior to use.The damage to the returned guidewire indicates the device encountered a significant force during use.An assignable cause of procedural factors will be assigned to the reported events: ¿guidewire distal tip stretched¿ and ¿guidewire does not have smooth movement¿ and analyzed events: ¿guidewire distal tip stretched¿ and ¿guidewire distal tip broken/fractured during use¿ 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 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 SOFT STRAIGHT 200CM
• 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: 21682663
• Report Number: 3012931345-2025-00067
• Device Sequence Number: 8500733
• Product Code: DQX
• UDI-Device Identifier: 04546540688729
• UDI-Public: (01)04546540688729(17)270312(10)0000633430
• 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): 03/24/2025

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: M00326010
• Device Lot Number: 0000633430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 03/24/2025
• 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: ASPIRATION CATHETER (UNKNOWN); XT-27 MICROCATHETER (STRYKER)
• Patient Sex: Unknown
• Patient Race: Asian