MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DIREXION HI-FLO FATHOM-16 SYSTEM; CATHETER, CONTINUOUS FLUSH

Model Number	84591
Medical Device Problem Codes	Entrapment of Device (1212); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a device was fracture occurred.The target lesion was in the esophageal varicose veins.A 130cm direxion hi-flo fathom-16 system was selected for use.During advancing to the lesion, the fathom guidewire was trapped within the catheter system and was removed as a unit.However, the device was noted to be fractured about half of the catheter, but it was confirmed that the device was completely removed without leaving fragments in the patient's body.As per physician's opinion, the fracture is possibly due to manufacturing defect.The procedure was completed with another of the same device.There were no patient complications reported.

• Brand Name: DIREXION HI-FLO FATHOM-16 SYSTEM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15129214
• Report Number: 2124215-2022-27720
• Device Sequence Number: 14814235
• Product Code: KRA
• UDI-Device Identifier: 08714729839682
• UDI-Public: 08714729839682
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K142259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2022

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 Expiration Date: 11/26/2023
• Device Model Number: 84591
• Device Catalogue Number: 84591
• Device Lot Number: 0028454217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2021
• 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: COIL- 18MM X 50CM PE F-IDC INTERLOCK
• Patient Sex: Unknown