MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO-14 STRAIGHT 300-35CM; WIRE, GUIDE, CATHETER

Catalog Number	M00313310
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure for middle cerebral artery mca stenosis, when the subject guidewire was used, the physician found it uncontrollable.Angiography revealed that the tip of the subject guidewire had fractured.The proximal segment of the guidewire was then withdrawn for retrieval, while attempts to remove the fractured distal segment using a snare were unsuccessful, leaving it inside the patient's body.The physician did not take further action regarding the retained fragment and subsequently completed the procedure using another guidewire.No further information is available.
Additional Manufacturer Narrative
D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿ updated.H3 device evaluated by mfg ¿ updated.B5 executive summary - updated.F10/h6 health impact code grid - health effect - impact code - updated.There are controls in the manufacturing process to ensure the product met specifications upon release.During visual/microscopic inspection, the distal end of the guidewire had been fractured.The fracture point exhibited a fracture to the nitinol tubing with evidence of torque forces; the core wire was fractured with bending noted to the fracture point.Approx.19cm of the guidewire had been fractured and not returned.Unable to perform functional testing as the device was fractured.The reported guidewire fracture and un-retrieved device fragments were confirmed during the analysis.The device failed to meet specification when received, based on the damage noted.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.This complaint was reported for nv - guidewire distal tip broken/fractured during use and nv - un-retrieved device fragments.It was reported that during the procedure, a synchro 0.014 300 guidewire was prepared for use.However, the physician found it uncontrollable.Angiography revealed that the tip of the guidewire had fractured.The proximal segment of the guidewire was then withdrawn for retrieval, while attempts to remove the fractured distal segment using a snare were unsuccessful, leaving it inside the patient's body.As per the additional information, the device was confirmed to be in good condition during preparation/prior to use on the patient, continuous flush was set up and maintained throughout the clinical procedure and the patient's anatomy was moderately tortuous.The wire was torqued to overcome the resistance, force was used to overcome resistance, and the vessel had 95% stenosis.The issue was noted when manipulating the product, the operator found the guidewire was broken.The physician tried to use synchro to go through the middle cerebral artery mca stenosis but at that time he found the handling was different with the image under x-ray, so he confirmed the guidewire fracture under x-ray.Tried to take the fractured tip out but failed.The guidewire was returned, and it was confirmed that approximately 19cm of the distal end of the guidewire had been fractured and not returned.It was reported that the guidewire was advanced and torqued against resistance, which can cause fractures to the guidewire.There was a high percentage of stenosis at the target site which is likely to have caused difficulties to advance and manipulate the guidewire causing the subsequent guidewire fracture.An assignable cause of procedural factors will be assigned to the reported guidewire distal tip broken/fractured during use and un-retrieved device fragments and to the analyzed guidewire 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.
Event or Problem Description
It was reported that during the procedure for middle cerebral artery mca stenosis, when the subject guidewire was used, the physician found it uncontrollable.Angiography revealed that the tip of the subject guidewire had fractured.The proximal segment of the guidewire was then withdrawn for retrieval, while attempts to remove the fractured distal segment using a snare were unsuccessful, leaving it inside the patient's body.The physician did not take further action regarding the retained fragment and subsequently completed the procedure using another guidewire.No further information is available.Additional information received on 14-oct-2025 stated that the patient has been discharged from the hospital and is now taking anticoagulant medication at home.

• Brand Name: SYNCHRO-14 STRAIGHT 300-35CM
• 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: 23300892
• Report Number: 3012931345-2025-00169
• Device Sequence Number: 18648890
• Product Code: DQX
• UDI-Device Identifier: 07613252186946
• UDI-Public: (01)07613252186946(17)251010(10)0000569995
• 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): 12/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/10/2025
• Device Catalogue Number: M00313310
• Device Lot Number: 0000569995
• 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: 09/19/2025
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male