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	01/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The guidewire (subject device) was returned for analysis, and it was observed that the guidewire poly tetra fluoro ethylene (ptfe) coating was peeling.Additionally, there was resistance with use of guidewire and has challenges while advancing a catheter over it.Also, the midsection and distal end tip of subject guidewire was kinked/bent.The subject device was reported to be replaced, and the procedure was reported to be completed successfully.No clinical consequences were reported to the patient.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the subject guidewire was seen to be kinked in the mid-section and distal end.The guidewire poly tetra fluoro ethylene (ptfe) coating was seen to be peeling.As a part of functional inspection, the subject guidewire was advanced into an insertion tool and subsequently through a demonstration sl-10 microcatheter.Friction was noted in areas of damage.The reported complaint was confirmed based on analysis.The device failed to meet specification when received for complaint investigation based on the analyzed anomalies noted to the device.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 ¿after thorough flushing, the guidewire was used in conjunction with a microcatheter to attempt access.However, the guidewire encountered difficulty in superselective catheterization at the distal end of the internal carotid artery (ica) and could not be advanced smoothly to the target site.The physician withdrew the guidewire for external inspection and found a kink in the posterior segment of the guidewire¿.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.Other devices used in the procedure in conjunction with the subject device was a microcatheter.The guidewire tip was shaped 90° degrees.There was difficulty tracking the catheter over the guidewire.The guidewire was not swapped and reused during the procedure.The proximal section of the guidewire was kinked.The same microcatheter was used to finish the procedure.Analysis of the returned device found the subject guidewire was kinked in the mid-section and distal end.When the guidewire was advanced into an insertion tool and subsequently through a demonstration sl-10 microcatheter, friction was noted in areas of damage.The damage to the returned guidewire indicates the device encountered a force during use.This most likely occurred as a result of the patient¿s severely tortuous anatomy.Based on review of all available information an assignable cause of procedural factors will be assigned to the reported event of 'guidewire friction¿, ¿guidewire proximal section kinked/bent¿ and ¿catheter has difficulty tracking over guidewire¿ and analysed event of 'guidewire friction', 'catheter has difficulty tracking over guidewire', 'guidewire distal end/tip kinked/bent', 'guidewire mid-section kinked/bent' 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.Analysis of the returned device also found the ptfe was peeling which indicates the ptfe coating was damaged due to interaction with an accessory device.The damage noted is consistent with backloading the proximal end of the guidewire into the distal end of the introducer and pulling it through the introducer.The analysed event of ¿guidewire ptfe coating peeling¿ will be assigned handling damage as the issue is due to handling of the product or portion of the product during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.

• 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: 24807857
• Report Number: 3012931345-2026-00071
• Device Sequence Number: 10667307
• Product Code: MOF
• UDI-Device Identifier: 07613327508499
• UDI-Public: (01)07613327508499(17)280414(10)0000818171
• 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): 04/07/2026

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: 0000818171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2025
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Race: Asian