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

Model Number M001195750

Device Problems Break (1069); Failure to Advance (2524)

Patient Problem Failure of Implant (1924)

Event Date 03/30/2023

Event Type  malfunction  

Event Description

Mid 50¿s female with history of fibroids and menorrhagia.Procedure: ir embolization- bilateral uterine artery embolization and image guided superior hypogastric nerve block.Device 1- wire would not feed into cather.Device 2- microcatheter broken @ hub.#3 obtained and used without issues.No known harm to patient, minor delay in procedure.Manufacturer response for catheter, continuous flush, direxion¿ hi-flo¿ (per site reporter) will obtain.Manufacturer response for catheter, continuous flush, direxion¿ hi-flo¿ fathom¿-16 system (per site reporter) will obtain.

• Brand Name: DIREXION¿ HI-FLO¿ FATHOM¿-16 SYSTEM
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 16731515
• MDR Text Key: 313221542
• Report Number: 16731515
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 08714729839729
• UDI-Public: (01)08714729839729(17)M001195750(10)29223804
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/30/2023

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
• Device Operator: Health Professional
• Device Model Number: M001195750
• Device Lot Number: 29223804
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/30/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/13/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/13/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18980 DA
• Patient Sex: Female
• Patient Weight: 110 KG