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

Catalog Number	M00326420
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.Visual/microscopic inspection was performed as the distal end of the subject guidewire was noted to be broken/fractured at 193cm from the proximal end.The core wire distal end was observed through the distal tip dome.A functional inspection could not be confirmed as the subject guidewire device was damaged.The reported ¿guidewire kinked/bent¿ can be confirmed based on the device analysis, it is likely that the physician observed the subject guidewire device to be kinked rather than fractured.The subject guidewire device failed to meet specification when returned for analysis, 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.It was reported that the physician used a subject guidewire device, and it became kinked.There was no additional information available, however it is documented on the returned labeling that the subject guidewire device was noted to be kinked when removed from the patient.The subject guidewire device was returned for analysis, and it was found that the distal tip of the subject guidewire device had been fractured rather than kinked, it is likely that the physician observed the subject guidewire device to be kinked rather than fractured.The analysis results are consistent with the reported event.It is probable that the subject guidewire device experienced friction and difficulties due to procedural and/or anatomical factors present during the clinical procedure, it is probable that the subject guidewire device then kinked and fractured.An assignable cause of procedural factors will be assigned to the as reported and as analyzed defects, 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
Analysis of the returned subject guidewire device revealed that the distal end of the subject guidewire was noted to be broken/fractured at 193cm from the proximal end during use.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: SYNCHRO2-14 STANDARD PRE-SHAPED 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: 20889990
• Report Number: 3012931345-2024-00210
• Device Sequence Number: 13022554
• Product Code: DQX
• UDI-Device Identifier: 04546540688774
• UDI-Public: (01)04546540688774(17)270204(10)0000618050
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2024

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: M00326420
• Device Lot Number: 0000618050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2024
• 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
• Patient Sex: Unknown