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

Model Number M001195720

Patient Problem Insufficient Information (4580)

Event Date 01/31/2024

Event Type  malfunction  

Event Description

During the coil embolization left internal iliac aneurysm procedure, the surgical team noticed that a few of our embolization coils would not deploy through our direxion microcatheter.There is no reason for this to happen as they are the correct size.Upon taking these coils out and trying new ones, the catheter broke in half at the hub.We were able to retrieve the entire catheter and remove it from the body.We opened another of the same catheter and this happened again.We opened a third microcatheter and were able to complete the procedure and the coils were able to be deployed other than a couple that were damaged.Procedure: pelvic arteriogram with embolization of the left internal iliac artery.Procedure indications: left internal iliac artery aneurysm.Ref report: mw5151327.

• Brand Name: DIREXION HI_FLO FATHOM 16 SYSTEM
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 18684814
• MDR Text Key: 335241045
• Report Number: MW5151328
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M001195720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 112 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White