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	05/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is 2nd of 2nd mdr.There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the guidewire distal end was seen to be kinked/bent.The guidewire was seen to be kinked/bent.The guidewire was seen to be broken/fractured.The core wire distal end was observed through the distal tip dome.For functional inspection, not carried out due to the damage.The reported event is covered in the device direction 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 guidewire distal end/tip kinked/bent was confirmed.The reported guidewire difficult to advance could not be replicated during device analysis; 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 during super selective catheterization, the physician encountered difficulty in maneuvering the guidewire smoothly.Despite applying additional external force, the guidewire could be barely withdrawn from the body.Upon inspection outside the body, it was discovered that the tip of the guidewire had deformed.Subsequently, the physician replaced the guidewire with the subject guidewire, but the same issue occurred during use.Additional information received indicates that the device was prepared for use as per the directions for use, the device was confirmed to be in good condition during preparation/prior to use on the patient, 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 kinking noted to the guidewire and to the distal end of the guidewire.There was a fracture noted to the nitinol tubing of the guidewire.The returned microcatheter was noted to be extensively kinked.Flattened to the distal end and damage to the distal tip.It is likely that the damage sustained to the microcatheter caused the reported events.An assignable cause of caused by other will be assigned to the reported guidewire difficult to advance and guidewire distal end/tip kinked/bent, and to the analyzed guidewire distal end/tip kinked/bent, guidewire kinked/bent and guidewire broken/fractured during use, as the investigation indicates that another device caused the issue event.
Event or Problem Description
It was reported that the physician used a guidewire to advance the microcatheter.However, during superselective catheterization, the physician encountered difficulty in maneuvering the guidewire smoothly.Upon inspection outside the body, it was discovered that the tip of the guidewire had deformed.The physician replaced the guidewire with a subject guidewire, but the same issue occurred during use.The physician replaced both the microcatheter and the guidewire and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.The subject device was returned for analysis and the device investigation revealed that a fracture noted to the nitinol tubing of the subject guidewire.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: 23072303
• Report Number: 3012931345-2025-00153
• Device Sequence Number: 9997115
• Product Code: DQX
• UDI-Device Identifier: 04546540688781
• UDI-Public: (01)04546540688781(17)270708(10)0000691591
• 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): 09/17/2025

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: 0000691591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2024
• 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: EXCELSIOR XT-27 MICROCATHETER (STRYKER)
• Patient Sex: Unknown
• Patient Race: Asian