MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO2-14 SUPPORT PRE-SHAPED 300CM; GUIDE, WIRE, CATHETER, NEUROVASCULATURE

Catalog Number	S2SPP14300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the severe stenosis case of middle cerebral arteries (mca), the physician used the subject guidewire and exchanged it to pass through the lesion site and reach the distal end of the m2 segment.During the process of withdrawal, approximately 5 cm of the subject guidewire's tip fractured at the stenosis site.Afterwards, the physician used a retriever stent to remove the subject guidewire fragment and concluded the procedure.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
D4 expiration date: updated d4 gtin: updated d9 product available to stryker: updated d9 returned to manufacturer on: updated h3 device evaluated by mfg: updated h4 manufacturing date: updated.There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the proximal end of the subject guidewire was inspected, and the nitinol tubing was fractured at 295cm with the core wire exposed and fractured and the platinum wire stretched.The distal end of the guidewire was not returned.The 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 specifications when returned, based on the damage noted.It was reported that the physician used subject guidewire, exchanged it to pass through the lesion site and reach the distal end of the m2 segment.Subsequently, a balloon catheter was delivered coaxially to the site and dilated.Then the guidewire was withdrawn.During this process, approximately 5 cm of the guidewire's tip was fractured at the stenosis site.Afterwards, the physician used a retriever stent to remove the guidewire fragment and concluded the procedure.Additional information provided by the customer indicated that 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 subject guidewire was returned, and it was confirmed to have been fractured with evidence of stretching.It was reported that the subject guidewire fractured during withdrawal at the stenosis site.It is probable that there were anatomical factors present at the stenosis site which may have caused the guidewire to become stretched and fractured during the attempt to remove 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 analyzed 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 during the severe stenosis case of middle cerebral arteries (mca), the physician used the subject guidewire and exchanged it to pass through the lesion site and reach the distal end of the m2 segment.During the process of withdrawal, approximately 5 cm of the subject guidewire's tip fractured at the stenosis site.Afterwards, the physician used a retriever stent to remove the subject guidewire fragment and concluded the procedure.No clinical consequences were reported to the patient due to this event.

• Brand Name: SYNCHRO2-14 SUPPORT PRE-SHAPED 300CM
• Common Device Name: GUIDE, WIRE, CATHETER, NEUROVASCULATURE
• 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: 23873591
• Report Number: 3012931345-2025-00199
• Device Sequence Number: 4619199
• Product Code: MOF
• UDI-Device Identifier: 07613327459661
• UDI-Public: (01)07613327459661(17)271107(10)0000747842
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K190843
• 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): 03/06/2026

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 Catalogue Number: S2SPP14300
• Device Lot Number: 0000747842
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2024
• 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: BALLOON CATHETER (UNKNOWN); GUIDEWIRE (LIKAI); INTERMEDIATE CATHETER (ZHONGTIAN); LONG SHEATH (LIKAI); STENT RETRIEVER (XINWEI)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Race: Asian