MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO2-14 STANDARD STRAIGHT 200CM; WIRE, GUIDE, CATHETER

Catalog Number	M00326410
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Coma (2417)
Date of Event	05/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During acute recanalization procedure for right anterior cerebral artery occlusion procedure, the operator delivered the intermediate catheter to the terminal segment of the internal carotid artery (ica) and attempted to cross the lesion using the subject guidewire with a microcatheter.The guidewire was flushed and successfully delivered through the occluded segment.The operator continued to manipulate it, however, the subject guidewire got fractured inside the anterior cerebral artery (aca).Subsequently, the operator used a retriever stent to entangle the subject guidewire and successfully withdrew it from the patient's anatomy.The patient is in coma and the cause of coma is unknown.
Event or Problem Description
During acute recanalization procedure for right anterior cerebral artery occlusion procedure, the operator delivered the intermediate catheter to the terminal segment of the internal carotid artery (ica) and attempted to cross the lesion using the subject guidewire with a microcatheter.The guidewire was flushed and successfully delivered through the occluded segment.The operator continued to manipulate it, however, the subject guidewire got fractured inside the anterior cerebral artery (aca).Subsequently, the operator used a retriever stent to entangle the subject guidewire and successfully withdrew it from the patient's anatomy.The patient is in coma and the cause of coma is unknown.
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 full guidewire was not returned only the fractured distal tip.The distal fragment was inspected, and the nitinol tubing was broken/fractured with the core wire exposed and broken roughly 7.8cm from the distal tip.The platinum coil was stretched.The core wire was observed through the distal tip dome.Functional inspection was not required.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 broken/fractured during use¿ was confirmed based on the analysis of the returned device.The reported event ¿patient complication¿ is not a product related code, therefore, could not be confirmed.The device failed to meet specification when returned for analysis.It was reported that after successfully delivering the guidewire through the occluded segment, the physician continued to manipulate it, during which the guidewire fractured inside the anterior cerebral artery (aca).The fractured portion was approximately 7 centimeters in length within the physician's body.Subsequently, the physician used a retriever stent to entangle the guidewire and successfully withdrew it from the body, leaving no fragments behind.Additional information received indicates that continuous flush was set up and maintained throughout the clinical procedure and the patient¿s anatomy was moderately tortuous.It is unknown if the guidewire was torqued to overcome the resistance and it is unknown if any force was used to overcome resistance.The device distal 7.8cm fractured section was returned, the nitinol tubing and core wire were fractured with stretching noted to the platinum coil.The damage noted to the device is indicative of forces being applied to the device during use, most likely during manipulation and retraction of the guidewire.An assignable cause of procedural factors will be assigned to the reported and analysed event: ¿guidewire broken/fractured during use¿ and to the analysed event: ¿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.It cannot be determined if the patient condition of coma was related to the guidewire fracture or if it was due to patient¿s pre-existing condition.Based upon medical review, the event observed in the complaint is anticipated in nature as per the device risk assessment and does not require escalation to senior management.An assignable cause of anticipated procedural complication will be assigned to the reported event: ¿patient complication¿, as a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labeling and/or risk documentation files.

• Brand Name: SYNCHRO2-14 STANDARD STRAIGHT 200CM
• 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: 22213408
• Report Number: 3012931345-2025-00103
• Device Sequence Number: 18175892
• Product Code: DQX
• UDI-Device Identifier: 04546540688767
• UDI-Public: (01)04546540688767(17)270823(10)0000712111
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K053268
• 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): 08/21/2025

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 Catalogue Number: M00326410
• Device Lot Number: 0000712111
• 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: 05/25/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2024
• 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: INTERMEDIATE CATHETER (UNKNOWN); REBAR18 MICROCATHETER (NON-STRYKER).; STENT RETRIEVER (UNKNOWN).
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female