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	07/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after opening the subject guidewire package, the physician found that the tip of subject guidewire was abnormal with a fractured coating.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 that after opening the subject guidewire package, the physician found that the tip of subject guidewire was abnormal with a fractured coating.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
Section b1 adverse event/product problem - corrected - no product problem.Section h1 type of reportable event - corrected - no malfunction.D4 expiration date: updated.D4 gtin: updated.D9 product available to stryker: updated.D9 returned to manufacturer on: updated.H3 device evaluated by mfg: updated.H4 manufacturing date: updated.There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the subject guidewire was returned with kinks/bends.The guidewire was seen to be fractured in numerous areas along the nitinol tubing.There was no peeling noted to the polytetrafluoroethylene (ptfe) coating.The functional inspection was not performed.The reported event is covered in the device direction 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 ptfe 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.It was reported that the subject guidewire was intended to be used.However, after opening the guidewire package, the physician found that the tip was abnormal with a fractured coating.The device was returned, and it was noted that the guidewire nitinol tubing was kinked/bent and was fractures in a number of locations, there was no peeling noted to the polytetrafluoroethylene (ptfe) coating.The damage noted to the device is indicative of removing the device from the dispenser hoop with force, or with insufficient flush to the hoop causing the guidewire not to be adequately lubricated during removal, this is indicated but the bending and fracturing to the distal nitinol tubing.An assignable cause of handling damage will be assigned to the analysed guidewire kinked/bent and guidewire distal tip broken/fractured during preparation, 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.The reported guidewire ptfe coating peeling was not conformed during the device analysis.It is probable that the damage was perceived to be to the polytetrafluoroethylene (ptfe) coating.An assignable cause of not confirmed will be assigned to the reported guidewire ptfe coating peeling.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• 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: 22800554
• Report Number: 3012931345-2025-00135
• Device Sequence Number: 8512388
• Product Code: MOF
• UDI-Device Identifier: 07613327508574
• UDI-Public: (01)07613327508574(17)270916(10)0000723907
• 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,Followup
• Report Date (Section B): 10/29/2025

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: 0000723907
• 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: 07/29/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2024
• 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
• Patient Sex: Unknown
• Patient Race: Asian