MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO SELECT-14 SUPPORT ST 215CM; GUIDE, WIRE, CATHETER, NEUROVASCULATURE

Catalog Number	SSUP215STR
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during endovascular treatment of an intracranial aneurysm procedure, while repositioning, the subject guidewire distal end got fractured.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 endovascular treatment of an intracranial aneurysm procedure, while repositioning, the subject guidewire distal end got fractured.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
D4 expiration date ¿ added.H4 manufacturing date ¿ added.Based on the results of the dhr (device history record) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.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.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.It was reported that during manipulation of the synchro guidewire in circulation distal to the stent mesh, the distal end of the guidewire fractured during repositioning.The additional information received indicates that the guidewire experienced resistance in the tip, where it broke.Some friction/resistance was encountered during the procedure and slight force was used to overcome resistance.The device was not returned for analysis.Based on a review of all available information it is probable that the resistance experienced at the tip of the wire and the force applied to overcome that resistance caused the guidewire to fracture.It is likely that there were procedural and/or anatomical factors present during the clinical procedure which caused the reported friction/resistance.Based on the review of all available information, an assignable cause of procedural factors will be assigned to the reported guidewire distal tip broken/fractured during use and guidewire difficult to advance, 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.
Additional Manufacturer Narrative
D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.H3 device evaluated by mfg ¿updated.H6 type of investigation, investigation findings, investigation conclusions are updated.Based on the results of the dhr (device history record) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.During visual inspection, the distal end of the subject guidewire was confirmed to be fractured.The distal end of the guidewire was not returned.The functional inspection was unable to perform as the guidewire was fractured.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.The reported guidewire fracture was confirmed.The reported difficulty to advance the guidewire was unable to be replicated, however the damage to the device is consistent with the reported event.The device failed to meet specification when received, based on the damage noted to the returned device.It was reported that during manipulation of the guidewire in circulation distal to the stent mesh, the distal end of the guidewire fractured during repositioning.The additional information received indicates that the guidewire experienced resistance in the tip, where it broke.Some friction/resistance was encountered during the procedure and slight force was used to overcome resistance.The device was returned, and it was confirmed to have been fractured to the distal tip.It is probable that the device fractured as a result of the resistance experienced and the slight force applied to overcome that resistance.Based on the review of all available information, an assignable cause of procedural factors will be assigned to the reported and analyzed ¿guidewire distal tip broken/fractured during use¿ and the reported ¿guidewire difficult to advance¿ , 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 endovascular treatment of an intracranial aneurysm procedure, while repositioning, the subject guidewire distal end got fractured.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: SYNCHRO SELECT-14 SUPPORT ST 215CM
• 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: 22873191
• Report Number: 3012931345-2025-00141
• Device Sequence Number: 10290809
• Product Code: MOF
• UDI-Device Identifier: 07613327508611
• UDI-Public: (01)07613327508611(17)270915(10)0000723574
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K202522
• 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): 01/12/2026

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: SSUP215STR
• Device Lot Number: 0000723574
• 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: 08/07/2025
• Supplement Date Received by Manufacturer: 10/22/2025; 12/18/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 11/14/2025; 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2024
• 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: AXS INFINITY LS (STRYKER).
• Patient Age: 54 YR
• Patient Sex: Female