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

Catalog Number	M00326410
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a surgical procedure for a wide-necked aneurysm in the m2 segment of the right mca middle cerebral artery, when the physician was using a subject guidewire for delivery, it was found that the subject guidewire had fractured inside the intermediate catheter.After the physician withdrew the intermediate catheter and removed the broken subject guidewire, they replaced it with a new guidewire, and the surgery was ultimately completed without any clinical consequence to the patient.
Additional Manufacturer Narrative
H3 device evaluated by mfg ¿updated.There are controls in the manufacturing process to ensure the product met specifications upon release.Visual and microscopic inspection of the returned guidewire revealed ptfe coating peeling.The guidewire was fractured and returned in two separate fragments.The proximal fragment exhibited a break along the nitinol tubing, with the core wire exposed at approximately 186 cm.The distal fragment was also fractured along the nitinol tubing, located roughly 14 cm from the distal tip.Functional inspection could not be performed due to the extent of damage to the device.The reported guidewire broken/fractured during use was confirmed based on the analysis of the returned device.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the 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.It was reported that when the physician was using a guidewire for delivery, it was found that the guidewire had fractured inside the intermediate catheter.After the physician withdrew the intermediate catheter and removed the broken guidewire, they replaced it with a new guidewire, and the surgery was ultimately completed smoothly.Additional information received indicates that continuous flush was set up and maintained throughout the clinical procedure and the patient's anatomy was severely tortuous.The wire was torqued to overcome the resistance, the issue was noted on the distal section of the guidewire, friction/resistance was encountered during the procedure, force was used to overcome resistance, and there was high tortuosity in the internal carotid artery (ica) relative to the tip of the guidewire position.The device was returned and it was confirmed that the distal section of the guidewire had been fractured.It was stated that the patient's anatomy was severely tortuous relative to the tip of the guidewire and that the guidewire was torqued and some force was used to overcome the resistance.Tortuosity in the location of the tip of the guidewire can cause additional pressure/friction to the tip of the guidewire, which can cause the tip to fracture during the attempt to torque or advance against this resistance.An assignable cause of procedural factors will be assigned to the reported and analyzed guidewire broken/fractured during use, as these defects are associated with a product that met stryker design and manufacturing specifications and was used in accordance with the directions for use (dfu) but performance was limited due to procedural and/or anatomical factors during use.The ptfe coating to the proximal end of the guidewire was noted to have some areas of peeling; this damage is indicative of interaction with an under-tightened torque device, either during use or during removal after use.An assignable cause of handling damage will be assigned to the analyzed guidewire ptfe coating peeling, as the issue is due to handling of the product or portion of the product during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.
Event or Problem Description
During a surgical procedure for a wide-necked aneurysm in the m2 segment of the right mca middle cerebral artery, when the physician was using a subject guidewire for delivery, it was found that the subject guidewire had fractured inside the intermediate catheter.After the physician withdrew the intermediate catheter and removed the broken subject guidewire, they replaced it with a new guidewire, and the surgery was ultimately completed without any clinical consequence to the patient.Additional information was received on 29 august 2025 stating that the issue was noted on the distal end of the guidewire.

• Brand Name: SYNCHRO2-14 STANDARD 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: 22885748
• Report Number: 3012931345-2025-00143
• Device Sequence Number: 9057428
• Product Code: DQX
• UDI-Device Identifier: 04546540688767
• UDI-Public: (01)04546540688767(17)271201(10)0000757868
• 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): 11/06/2025

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: M00326410
• Device Lot Number: 0000757868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2024
• 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: SILVER SNAKE 6F MIDDLE CATHETER(NON-STRYKER).
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 60 KG