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	12/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during intracranial stenosis procedure, while delivering the subject guidewire through the lesion site, the physician suspected that the middle part of the subject guidewire had fractured and withdrawn it.Upon inspection, the subject guidewire tip was found to be broken.After that, in the same procedure, the stent was prepared to deploy but resistance was felt when it entered the microcatheter and prevented it from being advanced and later on the stent was withdrawn and partially refracted it into the introducer sheath and also resistance was felt when removing the subject guidewire from dispenser hoop.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during intracranial stenosis procedure, while delivering the subject guidewire through the lesion site, the physician suspected that the middle part of the subject guidewire had fractured and withdrawn it.Upon inspection, the subject guidewire tip was found to be broken.After that, in the same procedure, the stent was prepared to deploy but resistance was felt when it entered the microcatheter and prevented it from being advanced and later on the stent was withdrawn and partially refracted it into the introducer sheath and also resistance was felt when removing the subject guidewire from dispenser hoop.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
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 inspection, the distal 9cm section of the guidewire was noted to have been fractured with fracturing to the nitinol tubing and core wire and extensive stretching to the platinum coil.The functional inspection was unable to perform due to damage.The reported events are 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 guidewire fracture was confirmed.The reported device difficulty to remove from packaging was unable to be replicated, however the analysis results are consistent with the reported event.The device failed to meet specification when returned, based on the damage noted.It was reported that when delivering the guidewire through the lesion site, the physician suspected that the middle part of the guidewire had fractured and thus withdrew it.Upon inspection, it was found that the tip of the guidewire had indeed broken.Additional information provided by the customer indicated that resistance was encountered removing the guidewire from the dispenser hoop, 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 patients anatomy was moderately tortuous.The guidewire was returned and it was confirmed that the distal end had been fractured, there was also extensive stretching noted.It cannot be definitively determined if the difficulty experienced in removing the guidewire form its dispenser hoop caused or contributed to the reported guidewire fracture, as it was also stated that the device was confirmed to be in good condition during preparation/prior to use on the patient.It is likely that any resistance experienced during removal from its dispenser hoop was due to handling of the device.Therefore, an assignable cause of handling damage will be assigned to the reported "device or component could not be removed from packaging".It is probable that there were procedural and/or anatomical factors present during the clinical procedure which caused the guidewire to become fractured during the advancement to the lesion site and the subsequent guidewire stretching during removal of the guidewire.An assignable cause of procedural factors will be assigned to the reported and analyzed "guidewire distal tip broken/fractured during use" and to the analysed "guidewire distal tip stretched", 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.

• 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: 24152573
• Report Number: 3012931345-2026-00013
• Device Sequence Number: 18628846
• Product Code: DQX
• UDI-Device Identifier: 04546540688781
• UDI-Public: (01)04546540688781(17)280603(10)0000841804
• 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): 03/10/2026

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: 0000841804
• 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: 12/31/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2025
• 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: NEUROFORM EZ STENT (STRYKER); XT-27 MICROCATHETER (STRYKER)
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 70 KG