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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during right middle cerebral artery occlusion case, the physician navigated the subject guidewire with an microcatheter to the target site.Attempts to go through the occlusion with the guidewire, but the delivery was unsuccessful after multiple tries, and it was subsequently noted that the guidewire tip had fractured within the vessel.The physician retracted the guidewire, retrieved the fractured segment using other device, and replaced the guidewire to successfully complete the recanalization.The procedure concluded smoothly, and the patient experienced no postoperative discomfort.
Additional Manufacturer Narrative
A2 age at time of event - corrected.A4 patient weight - added.A4 weight units - added.C2 / d10 concomitant products grid - added.D9 / h3 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.H3 device evaluated by mfg ¿updated.There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, it was observed that subject guidewire distal nitinol tubing had been separated from the guidewire core wire at the proximal bond.Could not perform functional test due to the condition of the returned device.The reported event is covered in the device direction 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 guidewire fracture, deformation & friction was confirmed based on the guidewire fracture that was noted during analysis.The reported difficulty engaging target vessel was not replicated as this is a procedural issue, however the damage to the device is consistent with the reported event.The device failed to meet specifications when received for complaint investigation, based on the damage noted.Additional information provided by the customer states that the device was prepared for use as per the directions for use, 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 patient's anatomy was severely tortuous which may have contributed to the reported event.It is probable that the patient's anatomy caused difficulties in advancing the guidewire and causing the subsequent guidewire fracture due to the attempts to manipulate the guidewire.An assignable cause of procedural factors will be assigned to the reported 'guidewire distal tip broken/fractured during use', 'guidewire deformed', 'guidewire friction' and 'device difficulty engaging target vessel' 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 right middle cerebral artery occlusion case, the physician navigated the subject guidewire with an microcatheter to the target site.Attempts to go through the occlusion with the guidewire, but the delivery was unsuccessful after multiple tries, and it was subsequently noted that the guidewire tip had fractured within the vessel.The physician retracted the guidewire, retrieved the fractured segment using other device, and replaced the guidewire to successfully complete the recanalization.The procedure concluded smoothly, and the patient experienced no postoperative discomfort.

• 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: 21991360
• Report Number: 3012931345-2025-00088
• Device Sequence Number: 8313148
• Product Code: DQX
• UDI-Device Identifier: 07613252186946
• UDI-Public: (01)07613252186946(17)250704(10)0000450047
• 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): 08/04/2025

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: 07/04/2025
• Device Catalogue Number: M00313310
• Device Lot Number: 0000450047
• 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: 04/18/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR SL-10 MICROCATHETER (STRYKER); SOLITAIRE STENT (MEDTRONIC)
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Race: Asian