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	12/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device was broken and removed with a snare.The 90% stenosed target lesion was located in the severely tortuous and severely calcified artery.A 300cm x 10cm guidewire was selected for use.During the procedure, it was noted that without any cause the device just broke off in the body.Afterwards the device would no longer fit through the rubicon guide catheter and then damaged the rubicon guide catheter.A snare was used to grab the broken part.The procedure was completed with a different device.No complications reported and the patient is in good condition after the procedure.

• Brand Name: FATHOM -14
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16206544
• Report Number: 2124215-2022-56156
• Device Sequence Number: 5454663
• Product Code: DQX
• UDI-Device Identifier: 08714729801047
• UDI-Public: 08714729801047
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 01/19/2023

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: 10/12/2025
• Device Model Number: 81725
• Device Catalogue Number: 81725
• Device Lot Number: 0030336899
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2022
• Initial Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2022
• 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