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	09/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the guidewire distal tip was noted to be slightly kinked/shaped.Torquer collet was inspected, no damage was noted (some poly tetra fluoro ethylene (ptfe) flaking was present).The core wire distal end was observed through the distal tip dome.The ptfe was seen to be damaged 30 cm from the proximal end.As a part of functional inspection, the guidewire was advanced through a flushed demonstration microcatheter without difficulties.A torque device was attached to the guidewire and guidewire was rotated without difficulties.The reported events ¿guidewire torque problem and guidewire friction¿ could not be duplicated; however, the analysis results are consistent with the reported event.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.Additional information provided by the customer indicated that there was no damage noted to the packaging prior to opening the packaging, while manipulating the proximal end of the guidewire, the physician rotated it both clockwise and counterclockwise, but there was no noticeable response at the distal end, and the tip of the guidewire failed to rotate and advance as directed by the physician's maneuvers.The patient¿s anatomy was moderately tortuous.During analysis the guidewire was noted to be kinked towards the distal tip.A demo torque device was used to manipulate the defect but could not be confirmed.It is probable due to the patient anatomy or stenosis and slight defect at the distal tip contributed to torquing the device.Based on review of all available information an assignable cause of procedural factors will be assigned to the reported event of ¿guidewire torque problem and guidewire friction¿ as these defects appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.An assignable cause of procedural factors will be assigned to the analyzed events of ¿guidewire distal end/tip kinked/bent and guidewire ptfe coating peeling¿ as these defects appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.
Event or Problem Description
The guidewire (subject device) was used in the medical procedure and was reported for difficulty in maneuvering and advancing as per the physician inputs.However, when the subject device was returned for analysis, it was noticed that the distal end of the subject device was kinked and the poly tetra fluoro ethylene coating over the guidewire was peeling.The subject device was reported to be replaced, and the procedure was reported to be completed without any clinical consequences to the patient.

• 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: 23610428
• Report Number: 3012931345-2025-00181
• Device Sequence Number: 9258499
• Product Code: MOF
• UDI-Device Identifier: 07613327508499
• UDI-Public: (01)07613327508499(17)280414(10)0000818179
• 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): 11/20/2025

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: 0000818179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 11/20/2025
• 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
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Race: Asian