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	08/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during stent implantation for middle cerebral artery stenosis, the physician noticed that the distal end of the subject guidewire did not move when manipulating it and upon re-examination under imaging, it was discovered that the tip of the guidewire had fractured.The physician advanced the microcatheter to a high position near the proximal point of the fractured subject guidewire part left inside patient's body.Through negative pressure aspiration, the fractured subject guidewire part was drawn into the microcatheter, which was then entirely withdrawn from the body.The guidewire was replaced and the procedure was completed successfully with no clinical consequences to the patient.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 stent implantation for middle cerebral artery stenosis, the physician noticed that the distal end of the subject guidewire did not move when manipulating it and upon re-examination under imaging, it was discovered that the tip of the guidewire had fractured.The physician advanced the microcatheter to a high position near the proximal point of the fractured subject guidewire part left inside patient's body.Through negative pressure aspiration, the fractured subject guidewire part was drawn into the microcatheter, which was then entirely withdrawn from the body.The guidewire was replaced and the procedure was completed successfully with no clinical consequences to the patient.
Additional Manufacturer Narrative
H3 device evaluated by mfg ¿updated.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 be kinked.The nitinol tubing was fractured from the core wire, and the full length of the core wire was exposed.The functional inspection was unable to be performed due to damage.The reported 'guidewire distal tip broken/fractured during use' was confirmed based on the analysis of the returned device.The reported 'device difficulty engaging target vessel' could not be replicated; 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 it was reported that the subject guidewire was further manipulated with the plan to advance the microcatheter through the stenotic site under its guidance.At this point, the physician noticed that the distal end of the subject guidewire did not move when manipulating it, and upon re-examination under imaging, it was discovered that the tip of the subject guidewire had fractured.Aspiration was used to remove the fraction section of the subject guidewire.Additional information received indicates that continuous flush was set up and maintained throughout the clinical procedure and the patient's anatomy was severely tortuous.Friction/resistance was noted when the subject guidewire was passing through the stenosis vessel and there was no resistance felt in the catheter.The device was returned, and it was confirmed that the distal tip of the subject guidewire had been fractured, there was also significant kinking noted to the subject guidewire.It was stated that the subject guidewire experienced friction in the location of the stenosed vessel, it is likely that the stenosis created friction to the distal tip preventing it from being maneuvered and subsequently fracturing the tip of the subject guidewire.An assignable cause of procedural factors will be assigned to the reported 'device difficulty engaging target vessel' and nv - guidewire distal tip broken/fractured during use' and to the analyzed 'guidewire kinked/bent' and 'guidewire distal tip broken/fractured', as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the directions for use (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: 22946616
• Report Number: 3012931345-2025-00147
• Device Sequence Number: 18419410
• Product Code: DQX
• UDI-Device Identifier: 07613252186922
• UDI-Public: (01)07613252186922(17)270219(10)0000792322
• 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): 11/13/2025

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: 0000792322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/12/2025
• Supplement Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 11/13/2025
• 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: MICROCATHETER (UNKNOWN).
• Patient Age: 59 YR
• Patient Sex: Unknown
• Patient Race: Asian