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

Model Number 84592

Device Problem Device-Device Incompatibility (2919)

Patient Problems Pain (1994); Vascular Dissection (3160)

Event Date 03/29/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter address 1: (b)(6).

Event Description

It was reported that there was a vascular dissection and the patient was in pain.The target lesion was located in the left bronchial artery.A direxion fathom-16 system was selected for use.During the procedure, it was noted that a vascular dissection occurred and the patient complained of pain.It was observed that fathom 18 guidewire was a little harder.At the beginning there has flow limiting.Consequently, the device was replaced with a different microcatheter and a 1/5 bottle of gelatin sponge particle was injected.Also, the vascular dissection was treated promptly.No further complications reported, and patient was stable post procedure.

• Brand Name: DIREXION FATHOM-16 SYSTEM
• Type of Device: 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14197824
• MDR Text Key: 290046830
• Report Number: 2134265-2022-04420
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K142259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 84592
• Device Catalogue Number: 84592
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female