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

Catalog Number	SSTD215STR
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the subject guidewire got fractured within the microcatheter due to resistance in the shaft.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 the subject guidewire got fractured within the microcatheter due to resistance in the shaft.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
G6 - report follow up- updated.H3 - device evaluated by mfg ¿ updated.Due to the automated manufacturing execution system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection it was noted that the guidewire was returned and the mid-section of the synchro select guidewire was seen to be kinked/bent.The guidewire ptfe (polytetrafluoroethylene) coating was seen to be peeling/scraping approximately 54cm from the proximal end.The guidewire nitinol tubing was seen to be broken/fractured 206cm from the proximal end, with the platinum coil and core wire exposed and broken/fractured.The surface of the nitinol tubing, platinum coil and core wire were rough.The functional inspection was unable to be performed due to damage.The reported event guidewire broken/fractured during use' was confirmed based on the analysis of the returned device.The reported event guidewire difficult to advance' could not be replicated; however, the analysis results are consistent with the reported event.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 ¿the subject guidewire got fractured within the microcatheter due to resistance in the shaft¿.Additional information provided by the customer did not indicate any issues noted during unpacking or set up of the device, and the device was prepared as per dfu instructions.The dispenser hoop was flushed before removing the guidewire.There was no indication of a user related issue.The anatomy was reported to be severely tortuous.The defect was not identified at the time of preparation.Friction or resistance was encountered in the catheter shaft.The guidewire (gw) was shaped 45 degree.The middle part of the subject device was found to be damaged.No resistance or friction was encountered when inserting the gw into the introducer sheath.No other difficulties were encountered during the usage of the device that could have contributed to the issue.There was no allegation against the microcatheter.The subject guidewire was returned and analyzed.The distal end was not returned.The guidewire nitinol tubing was broken/fractured 206cm from the proximal end, with the platinum coil and core wire exposed and broken/fractured.The surface of the nitinol tubing, platinum coil and core wire were rough.The mid-section of the guidewire was kinked/bent.The guidewire ptfe coating was seen to be peeling/scraping approximately 54cm from the proximal end.The damage to the guidewire indicates a significant force was used during the procedure which may have been due to the patient¿s severely tortuous anatomy.Based on the review of all available information an assignable cause of procedural factors will be assigned to the reported guidewire broken/fractured during use¿ and guidewire difficult to advance¿ and to the as analyzed guidewire mid-section kinked/bent', ' and guidewire broken/fractured during use' and 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.A cause of undeterminable has been assigned to the as analyzed guidewire ptfe coating peeling'.Analysis of the returned device also found evidence of scraping and peeling of the ptfe guidewire coating approximately 54cm from the proximal end.The peeling/scraping most likely occurred as a result of interaction with another device.The damage noted is consistent with either backloading the proximal end of the guidewire into the distal end of the introducer and pulling it through the introducer or due to the torque device not being adequately tightened which would allow the device to move up and down the proximal end of the guidewire, resulting in the peeling/scraping ptfe coating.However, this cannot be confirmed as the torque device and the introducer sheath were not returned for analysis.Therefore, a cause of undeterminable has been assigned to the as analyzed guidewire ptfe coating peeling'.

• Brand Name: SYNCHRO SELECT-14 STANDARD 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: 23658856
• Report Number: 3012931345-2025-00187
• Device Sequence Number: 4903850
• Product Code: MOF
• UDI-Device Identifier: 07613327508499
• UDI-Public: (01)07613327508499(17)280715(10)0000885058
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K202522
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2026

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: SSTD215STR
• Device Lot Number: 0000885058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2025
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER)
• Patient Sex: Unknown