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

Model Number	84591
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Material Integrity Problem (2978)
Health Effect - Clinical Code	Vasoconstriction (2126)
Date of Event	04/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter was difficult to remove.The target lesion was in the not very tortuous uterus.A direxion hi-flo fathom-16 system was selected for use.During procedure, the catheter was used to embolize a uterine fibroid with embolic beads.Some resistance was felt in the final approach to the target.Physician thought there might be vasospasm.The embolics were delivered and upon retraction of the device, it was noted that more resistance than they are typically used to was felt.Using very gentle pulling force, the catheter was removed and the separation of the yellow tip from the nitinol tube was noticed.The yellow tip showed separated from nitinol hypotube; however, it did not become fully detached and was removed intact.The procedure was completed with this device.No patient complications were reported.

• Brand Name: DIREXION HI-FLO FATHOM-16 SYSTEM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11863407
• Report Number: 2134265-2021-06239
• Device Sequence Number: 3790052
• Product Code: KRA
• UDI-Device Identifier: 08714729839682
• UDI-Public: 08714729839682
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/21/2021

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 Expiration Date: 10/28/2022
• Device Model Number: 84591
• Device Catalogue Number: 84591
• Device Lot Number: 0026261100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 05/21/2021
• Patient Sequence Number: 1