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

Model Number 84592

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2024

Event Type  malfunction  

Event Description

It was reported that the outer layer of the microcatheter peeled off.A direxion fathom-16 system was selected for use in the joint embolization procedure.The direxion fathom-16 system was introduced via the guide sheath.During advancement, it was noted that the direxion was unable to be controlled in the same manner in which it usually was.The physician elected to replace the direxion, but there was difficulty removing the device from the guide sheath.Once the direxion was removed, it was observed that the outer layer of the device coating had come off.The direxion was replaced with another direxion, and the procedure was completed using the second device.There were no reported patient complications, and the patient was reported to have fully recovered.

Event Description

It was reported that the outer layer of the microcatheter peeled off.A direxion fathom-16 system was selected for use in the joint embolization procedure.The direxion fathom-16 system was introduced via the guide sheath.During advancement, it was noted that the direxion was unable to be controlled in the same manner in which it usually was.The physician elected to replace the direxion, but there was difficulty removing the device from the guide sheath.Once the direxion was removed, it was observed that the outer layer of the device coating had come off.The direxion was replaced with another direxion, and the procedure was completed using the second device.There were no reported patient complications, and the patient was reported to have fully recovered.It was further reported that once removed, it was observed that the outer gray sheath of the direxion fathom-16 was defective, and the inner purple layer of the device was visible.

Manufacturer Narrative

Device analysis: the device was examined visually, and it was found that there were three fractures in the nitinol shaft, approximately 23.5cm, 24.3cm, and 25cm from the microcatheter hub.The device was not separated, and the purple inner layer of the device was visible, and intact.No other visual damage was noted during the investigation.

Event Description

It was reported that the outer layer of the microcatheter peeled off.A direxion fathom-16 system was selected for use in the joint embolization procedure.The direxion fathom-16 system was introduced via the guide sheath.During advancement, it was noted that the direxion was unable to be controlled in the same manner in which it usually was.The physician elected to replace the direxion, but there was difficulty removing the device from the guide sheath.Once the direxion was removed, it was observed that the outer layer of the device coating had come off.The direxion was replaced with another direxion, and the procedure was completed using the second device.There were no reported patient complications, and the patient was reported to have fully recovered.It was further reported that once removed, it was observed that the outer gray sheath of the direxion fathom-16 was defective, and the inner purple layer of the device was visible.

• Brand Name: DIREXION FATHOM-16 SYSTEM
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18610002
• MDR Text Key: 334806895
• Report Number: 2124215-2024-04675
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 08714729839637
• UDI-Public: 08714729839637
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K142259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/09/2024

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: 84592
• Device Catalogue Number: 84592
• Device Lot Number: 0032627309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 01/30/2024
• Supplement Dates Manufacturer Received: 02/09/2024; 03/21/2024
• Supplement Dates FDA Received: 03/05/2024; 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1