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

Catalog Number	M00326010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during mca (middle cerebral artery) thrombectomy case, when the operator tried to place the subject guidewire to distal of vessel and during super selecting of the subject guidewire, for better supporting the operator rotated the subject guidewire, but the distal of it had no reaction.When checked, found mid of the subject the guidewire fractured.Solitaire ab stent was used as a medical intervention to capture the tip of the subject guidewire and withdrew it.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the guidewire was returned broken in two fragments (192cm and 8cm), the proximal fragment was inspected, and the nitinol tubing was broken/fractured, the distal fragment was inspected, and the nitinol tubing was broken with the core wire and platinum wire exposed, and the core wire was seen through the distal tip dome.A functional inspection was not available as the guidewire was broken/fractured.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 complaint was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomaly noted to the device.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared for use as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, the patient's anatomy was moderately tortuous, the guidewire tip was shaped 45 degrees, no friction/resistance was encountered during the procedure, the issue occurred when delivering the guidewire to pass the lesion, a non -stryker stent was used to capture and withdraw the fractured guidewire, and no fragments were left inside the patient.The guidewire was returned broken in two fragments (192cm and 8cm).During visual inspection, the nitinol tubing was found to be broken/fractured on the proximal and distal fragments with the core wire and platinum wire exposed on the distal fragment.No other anomalies were noted to the returned device.Based on the analysis and information provided, it is probable that the guidewire experienced high tension and/or torsion forces during delivery which caused the wire to fracture.An assignable cause of procedural factors will be assigned to the as reported and as analyzed 'guidewire broken/fractured during use' since this issue is associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu but performance was limited due to procedural and/or anatomical factors during use.
Event or Problem Description
It was reported that during mca (middle cerebral artery) thrombectomy case, when the operator tried to place the subject guidewire to distal of vessel and during super selecting of the subject guidewire, for better supporting the operator rotated the subject guidewire, but the distal of it had no reaction.When checked, found mid of the subject the guidewire fractured.Solitaire ab stent was used as a medical intervention to capture the tip of the subject guidewire and withdrew it.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: SYNCHRO2-14 SOFT 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: 18489246
• Report Number: 3012931345-2024-00006
• Device Sequence Number: 19755653
• Product Code: DQX
• UDI-Device Identifier: 04546540688729
• UDI-Public: 04546540688729
• 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): 02/07/2024

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: 02/11/2026
• Device Catalogue Number: M00326010
• Device Lot Number: 0000223826
• 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: 12/21/2023
• Supplement Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2023
• 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: REBAR 18 CATHETER (NON-STRYEKR).; SOLITAIRE AB STENT (NON-STRYKER).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female