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	07/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the subject guidewire became fractured inside the microcatheter.The guidewire was replaced and the procedure was completed successfully with no clinical consequences to the patient.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added h3 device evaluated by mfg ¿updated d4 expiration date - added d4 - gtin - added d9 product available to stryker ¿ updated d9 returned to manufacturer on ¿updated due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.During the visual inspection, the subject guidewire was returned in two fragments.The proximal end was inspected, and two fractures were noted with the core wire exposed at roughly 189.5cm and 190cm.The distal end was inspected, and the platinum wire was stretched.The core wire was observed through the distal tip dome.The functional inspection was not performed due to the subject guidewire being broken/fractured.The reported 'guidewire broken/fractured during use' was confirmed.The device failed to meet specification when returned for analysis.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 operator was rotating the tail end of the subject guidewire, there was no change at the front end of the guidewire.Then, the physician withdrew the microcatheter and the subject guidewire and found that the subject guidewire was fractured during an external inspection.Additional information provided by the customer indicated that the device was prepared for use as per the dfu.There was no damage noted to the packaging prior to opening the packaging.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 patients anatomy was moderately tortuous.The same microcatheter was used to finish the procedure.The device was returned and it was confirmed that the subject guidewire had been fractured at approx.10cm from the distal tip, there was also stretching noted to the subject guidewire.It is probable that there may have been anatomical and/or procedural factors present during the clinical procedure that may have caused the reported subject guidewire fracture, it is probable that the subject guidewire was then stretched during removal from the patient.An assignable cause of procedural factors will be assigned to the reported and 'guidewire broken/fractured during use' as well as the analyzed 'guidewire distal tip broken/fractured during use' and '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.
Event or Problem Description
It was reported that the subject guidewire became fractured inside the microcatheter.The guidewire was replaced and the procedure was completed successfully with no clinical consequences to the patient.

• 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: 22624026
• Report Number: 3012931345-2025-00122
• Device Sequence Number: 9261090
• Product Code: DQX
• UDI-Device Identifier: 04546540688729
• UDI-Public: (01)04546540688729(17)271121(10)0000753773
• 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): 10/13/2025

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: 0000753773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/04/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2024
• 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: REBAR18 MICROCATHETER (NON STRYKER).
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 63 KG
• Patient Race: Asian