MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO-14 STRAIGHT 200-35CM; WIRE, GUIDE, CATHETER

Catalog Number	M00313010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during treatment of an infarction in the a2 segment of the left anterior cerebral artery (aca), the operator successfully delivered a long sheath to the target location and a pathway was established using an intermediate catheter, a microcatheter, and the subject guidewire.Subsequently, the operator attempted thrombectomy using a stent retriever, but the results were unsatisfactory after two attempts.During the third superselective navigation with the subject guidewire, the torque control at the guidewire tip was inadequate.Upon withdrawal, slight deformation of the subject guidewire tip was observed.When further superselective navigation was attempted with the same guidewire, it completely lost torque control.Upon retraction and inspection, it was found that the tip of the subject guidewire was fractured and the core wire remained intact.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 during treatment of an infarction in the a2 segment of the left anterior cerebral artery (aca), the operator successfully delivered a long sheath to the target location and a pathway was established using an intermediate catheter, a microcatheter, and the subject guidewire.Subsequently, the operator attempted thrombectomy using a stent retriever, but the results were unsatisfactory after two attempts.During the third superselective navigation with the subject guidewire, the torque control at the guidewire tip was inadequate.Upon withdrawal, slight deformation of the subject guidewire tip was observed.When further superselective navigation was attempted with the same guidewire, it completely lost torque control.Upon retraction and inspection, it was found that the tip of the subject guidewire was fractured and the core wire remained intact.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
H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.D4 expiration date - added.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.D4 gtin - updated.There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection the guidewire was fractured along the nitinol tubing.The proximal fragment was fractured at 185cm and the distal 9.5.The platinum wire was stretched.The core wire was seen through the distal tip dome.Functional inspection could not be performed due to device damage.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.The reported event ¿guidewire distal tip broken/fractured during use¿ was confirmed during analysis.The reported event: ¿guidewire torque problem¿ could not be replicated; however, the analysis results are consistent with the reported event.The reported event: ¿distal tip damage¿ can be confirmed based on the damage noted.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information received indicates that continuous flush was set up and maintained throughout the clinical procedure and the patients anatomy was moderately tortuous.The guidewire was returned and analysis confirmed that the distal section of the guidewire had been fractured and stretched.The available information states that the guidewire had been used for passes with the stent retriever and on the third pass some deformation was noted, the guidewire was used for another attempt and then lost its torque control and was fractured.It is probable that the guidewire was damaged and possibly may have sustained fractures to the nitiniol tubing on the third attempt which may have been further damaged on the 4th attempt.The guidewire may have become fatigued due to the multiple uses, causing it to fracture, the moderately tortuous anatomy may also have contributed to the reported events.An assignable cause of procedural factors will be assigned to the reported events: ¿guidewire distal tip broken/fractured during use¿, ¿guidewire torque problem¿ and ¿guidewire distal tip damaged¿ and the analyzed events: ¿guidewire distal tip broken/fractured during use¿, ¿guidewire distal tip stretched¿, 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-14 STRAIGHT 200-35CM
• Common Device Name: WIRE, GUIDE, CATHETER
• 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: 22731685
• Report Number: 3012931345-2025-00132
• Device Sequence Number: 18247346
• Product Code: DQX
• UDI-Device Identifier: 07613252186922
• UDI-Public: (01)07613252186922(17)270219(10)0000792320
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K002907
• 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): 10/24/2025

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: M00313010
• Device Lot Number: 0000792320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2025
• 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: GMAX LONG SHEATH (NON-STRYKER).; SILVER SNAKE INTERMEDIATE CATHETER (NON-STRYKER).; ZHONGTIAN MICROCATHETER (NON-STRYKER).
• Patient Sex: Unknown
• Patient Race: Asian