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	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during treatment of a right internal carotid artery (ica) to middle cerebral artery (mca) stenosis, a subject guidewire was used in conjunction with a microcatheter to establish access for stent implantation.During advancement of the subject guidewire and microcatheter to the distal ica, the subject guidewire could not be successfully superselected or positioned.The devices were withdrawn, and it was observed that the subject guidewire tip had stretched.However, the subject guidewire was returned for analysis and was examined.During device investigation and analysis, it was discovered that the subject guidewire distal tip was broken/fractured during use.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
This is 1 of 2 mdr's (2nd mdr).There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection the guidewire was kinked roughly 83cm.The guidewire was fractured along the nitinol tubing with the platinum wire stretched.The core wire was observed trough the distal tip come.Functional inspection was not required.The reported event ¿guidewire distal tip stretched¿ was confirmed during analysis.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 during the process of establishing access using the microcatheter and guidewire, when the guidewire was advanced with the microcatheter to the distal internal carotid artery (ica), the guidewire was difficult to super select at the distal ica and could not be successfully positioned.After the physician fully withdrew the products, inspection revealed that the tip of the microcatheter was bent, and the tip of the subject guidewire had stretched.The patients anatomy was moderately tortuous.During analysis the guidewire was returned with a rigid fracture along the nitinol tubing exposing the core wire and the platinum wire was stretched.It is probable that the tortuosity caused difficulty resulting in the fracture.An assignable cause of procedural factors will be assigned to the reported event ¿guidewire distal tip stretched and ¿device difficulty engaging target vessel¿ 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.An assignable cause of procedural factors will be assigned to the analysed event ¿guidewire distal tip stretched¿ and ¿guidewire distal tip broken/fractured during use¿ 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.

• 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 ; +1(510)413-2500
• MDR Report Key: 50774723
• Report Number: 3012931345-2026-00140
• Device Sequence Number: 13129531
• Product Code: MOF
• UDI-Device Identifier: 07613327508499
• UDI-Public: (01)07613327508499(17)280812(10)0000936222
• 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): 09/15/2026

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: 0000936222
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/05/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2025
• 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 XT-27 Microcatheter (Stryker)
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 167 LB
• Patient Race: Asian