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	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The guidewire (subject device) was returned for analysis, and it was discovered that there was skiving noted to the polytetrafluoroethylene (ptfe) coating to the proximal end of the guidewire (subject device).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
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 guidewire was seen to have polytetrafluoroethylene (ptfe) skiving from 150 cm.The core wire was observed through the distal tip dome, and the outer diameter (od) dry was 0.0137.The guidewire was soaked in water for approx.2 minutes.No anomalies were noted.During functional inspection the guidewire was soaked for approx.2 mins and advanced through a flushed demo sl-10.No friction was noted.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 difficult to advance was not replicated during the device analysis, however a review of the available data indicates a probable cause for the reported event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that, after thorough rinsing, the guidewire, along with an sl-10 microcatheter, was advanced through the bifurcation vessel for super selective catheterization.When the guidewire had traveled approximately halfway inside the microcatheter, the physician encountered significant resistance and a rough feeling, making the advancement difficult.Additional information provided by the customer indicated that 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 patient's anatomy was moderately tortuous.The guidewire tip was shaped 90° and resistance was felt at the distal end of the catheter.The guidewire was returned for analysis; there were no visual anomalies noted which could have caused or contributed to the reported event.There was skiving noted to the polytetrafluoroethylene (ptfe) coating to the proximal end of the guidewire, however this is unrelated to the reported event.The guidewire was advanced through a demonstration sl-10 microcatheter without difficulty.Based on the review of all available information, it is probable that the reported tortuosity of the patient's anatomy may have caused or contributed to the reported difficulty to advance the guidewire.An assignable cause of procedural factors will be assigned to 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.It is probable that the guidewire ptfe coating was damaged during insertion through the introducer or due to removal of the torque device after use.An assignable cause of handling damage will be assigned to the 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: 23316755
• Report Number: 3012931345-2025-00170
• Device Sequence Number: 14909659
• Product Code: DQX
• UDI-Device Identifier: 07613327508499
• UDI-Public: (01)07613327508499(17)280211(10)0000789425
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 10/16/2025

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: SSTD215STR
• Device Lot Number: 0000789425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2025
• 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 Age: 64 YR
• Patient Sex: Male
• Patient Race: Asian