MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FATHOM -14; WIRE, GUIDE, CATHETER

Model Number	81725
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that device fracture occurred.The target lesion was located in the severely tortuous and moderately calcified vessel.Two 200 cmx10 cm fathom-14 guidewire were selected for use.During advancing, it was noted that device fracture occurred approximately 6 inches from the top of the wire.This device was snared and since the second device was still connected, it was easily removed.As per physician's opinion, the fracture was possibly caused by the tortuosity of the vessel and going through stent.The procedure was completed with a different device.There were no complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device and a torque device were returned for the analysis, and it is possible to see that the guidewire was kinked at the middle and distal section and detached at the distal section.No more damages were detected.Microscope inspection revealed that under the microscope it was observed that the guidewire was observed detached at the distal section.
Event or Problem Description
It was reported that device fracture occurred.The target lesion was located in the severely tortuous and moderately calcified vessel.Two 200 cmx10 cm fathom-14 guidewire were selected for use.During advancing, it was noted that device fracture occurred approximately 6 inches from the top of the wire.This device was snared and since the second device was still connected, it was easily removed.As per physician's opinion, the fracture was possibly caused by the tortuosity of the vessel and going through stent.The procedure was completed with a different device.There were no complications reported.

• Brand Name: FATHOM -14
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17079646
• Report Number: 2124215-2023-27091
• Device Sequence Number: 2173695
• Product Code: DQX
• UDI-Device Identifier: 08714729801023
• UDI-Public: 08714729801023
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K111498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2023

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: 03/06/2026
• Device Model Number: 81725
• Device Catalogue Number: 81725
• Device Lot Number: 0031183269
• 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: 05/16/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown