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

Model Number	M001195960
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Patient with recent history of abdominal pain, hematemesis, cardiac arrest followed by resuscitation was admitted for an interventional radiology embolization.The pre-loaded torqueable microcatheter from the direxion¿ hi-flo¿ fathom¿-16 system broke off during the procedure.Everything was removed without known harm to the patient.The faulty device was exchanged to continue with the procedure.

• Brand Name: DIREXION HI-FLO FATHOM-16 SYSTEM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12352763
• Report Number: 12352763
• Device Sequence Number: 17088798
• Product Code: KRA
• UDI-Device Identifier: 08714729991069
• UDI-Public: (01)08714729991069(17)210813(10)24266257
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/17/2021
• Report Date (Section F): 08/17/2021

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 Model Number: M001195960
• Device Catalogue Number: M001195960
• Device Lot Number: 24266257
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/23/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 78
• Date Report Sent to FDA: 08/17/2021