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

Catalog Number	SSFT215STR
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, when the guidewire was removed from the hoop and used, the coating was peeling off, making it impossible to use.The guidewire was replaced and the procedure was completed successfully with no clinical consequences to the patient.
Event or Problem Description
It was reported that during the procedure, when the guidewire was removed from the hoop and used, the coating was peeling off, making it impossible to use.The guidewire was replaced and the procedure was completed successfully with no clinical consequences to the patient.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿ updated.D4 expiration date ¿ added.D4 gtin # - added.Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.During the visual inspection, the subject guidewire was noted to have ptfe coating damaged at roughly 60cm.There was a kink noted to the distal tip of the subject guidewire.There was no damage noted to the hydrophilic coating in its dry or hydrated state.During the functional inspection, it was not attempted to advance the subject guidewire through the returned microcatheter due to the damage and occlusion noted within the microcatheter.The subject guidewire was advanced through a demonstration microcatheter without difficulty.The as reported 'hydrophilic coating peeling' was not confirmed during analysis.The device failed to meet specifications 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 when the subject guidewire was removed from the hoop and used, the coating was peeling off, making it impossible to use.The same product was opened and used again, and the procedure was completed.No further information was available.The device was returned, and the distal tip of the subject guidewire was noted to be kinked, there was some very slight damage noted to the proximal ptfe coating.It is likely that the subject guidewire was damaged during removal from its dispenser hoop, possibly due to insufficient flush within the hoop.It is probable that the kink to the distal tip was perceived and reported to damage to the hydrophilic coating, as this is the location of the hydrophilic coated section of the guidewire.The was some very slight damage noted to the proximal ptfe coating, which may also have been caused during removal from the hoop.An assignable cause of not confirmed will be assigned to the as reported 'hydrophilic coating peeling', as there was no damage or peeling noted to the hydrophilic coating.An assignable cause of handling damage will be assigned to the as analyzed 'guidewire ptfe coating peeling' and 'guidewire distal end/tip kinked/bent', 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 SOFT 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: 22851039
• Report Number: 3012931345-2025-00138
• Device Sequence Number: 15547010
• Product Code: MOF
• UDI-Device Identifier: 07613327508574
• UDI-Public: (01)07613327508574(17)270619(10)0000681529
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2025

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: SSFT215STR
• Device Lot Number: 0000681529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2024
• 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: SL 10 MICROCATHETER (STRYKER).
• Patient Sex: Unknown