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	01/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an internal carotid artery (ica) aneurysm case, physician used subject guidewire and while navigating it to the distal target location, physician found distal tip of subject guidewire broken/fractured.A snare device was used to remove the broken segment of the subject guidewire from the patient¿s body as a medical intervention.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully with another device.
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during an internal carotid artery (ica) aneurysm case, physician used subject guidewire and while navigating it to the distal target location, physician found distal tip of subject guidewire broken/fractured.A snare device was used to remove the broken segment of the subject guidewire from the patient¿s body as a medical intervention.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully with another device.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.The subject guidewire was not returned for analysis; therefore, physical as well as a functional testing could not be performed.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 complaint was unable to be confirmed and it cannot be confirmed that the device met specification, as the device was not returned.Additional information provided by the customer indicated that the broken segment of the subject guidewire was removed from the patient¿s body with a snare device.The device 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, the patient¿s anatomy was moderately tortuous.As the subject guidewire was not returned for analysis and a review of all available information fails to indicate an assignable cause for the reported event, an assignable cause of undeterminable will be assigned to this complaint.
Event or Problem Description
It was reported that during an internal carotid artery (ica) aneurysm case, physician used subject guidewire and while navigating it to the distal target location, physician found distal tip of subject guidewire broken/fractured.A snare device was used to remove the broken segment of the subject guidewire from the patient¿s body as a medical intervention.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully with another device.
Additional Manufacturer Narrative
D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿ updated.H3 device evaluated by mfg ¿ updated.There are controls in the manufacturing process to ensure the product met specifications upon release.During visual and microscopic inspection, it was observed that subject guidewire was seen to be kinked.The nitinol tubing was fractured completely off the core wire at the proximal bond.There was an additional break towards the distal end of the nitinol tubing.Functional inspection was unable to perform due to 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 tip broken/fractured during use was confirmed during analysis.The device failed to meet specification when returned based on the damage noted to the returned device.Additional information provided by the customer indicated that the broken segment of the subject guidewire was removed from the patient's body with a snare.The device 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, the patient¿s anatomy was moderately tortuous.The device was returned, and it was confirmed that the nitinol tubing had fractured and separated from the core wire at the proximal bond, there was also a fracture to the nitinol tubing to the distal end of the subject guidewire.There was some kinking noted to the proximal end of the subject guidewire.It is probable that there were anatomical and/or procedural factors present during the clinical procedure which caused the subject guidewire to fracture and separate during use.An assignable cause of procedural factors will be assigned to the reported and analyzed event guidewire distal tip broken/fractured during use and to the analyzed event guidewire kinked/bent and guidewire broken/fractured during use.

• 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: 18516767
• Report Number: 3012931345-2024-00007
• Device Sequence Number: 15396855
• Product Code: DQX
• UDI-Device Identifier: 04546540688729
• UDI-Public: (01)04546540688729(17)260219(10)0000226426
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup
• Report Date (Section B): 01/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/19/2026
• Device Catalogue Number: M00326010
• Device Lot Number: 0000226426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/04/2024
• Supplement Date Received by Manufacturer: 02/13/2024; 12/12/2025
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 03/01/2024; 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2023
• 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)
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Male