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	01/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a body procedure, subject guidewire was broken.No further information is available.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.During visual/microscopic inspection, the guidewire was returned broken in three segments (182.5cm, 9cm and 7.9cm).The proximal fragment was inspected, and the nitinol tubing was broken/fractured.The middle fragment was inspected, and the nitinol tubing was broken with the core wire and platinum wire exposed.The core wire was seen through the distal tip dome of the distal fragment.Functional inspection was not applicable 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.It was reported that using guidewire in a body case.A piece of the wire broke off.As per the available information the guidewire was used in a body case and not a neuro case.It was in the vascular system in the foot.The guidewire was returned with 2 distal fragments fractures and detached.It cannot be determined if the anatomical location of the treatment site may have caused or contributed to the reported event.Based on review of all information and results of the device analysis, it is probable that the guidewire was subject to excessive forced during use causing the guidewire to fracture, this is evident from the damage noted to the fracture points.An assignable cause of ¿procedural factors¿ will be assigned to the as reported and as analyzed ¿guidewire broken/fractured during use¿, as 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 a body procedure, subject guidewire was broken.No further information is available.

• 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: 18778941
• Report Number: 3012931345-2024-00028
• Device Sequence Number: 8531493
• Product Code: DQX
• UDI-Device Identifier: 04546540688729
• UDI-Public: 04546540688729
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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): 04/03/2024

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: M00326010
• Device Lot Number: 0000583004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2024
• Supplement Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2023
• 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
• Patient Sex: Unknown