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

Model Number	84591
Medical Device Problem Codes	Entrapment of Device (1212); Detachment of Device or Device Component (2907); Positioning Problem (3009)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	02/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.Inspection of the device revealed no damage and was fully intact, however; a guidewire was stuck inside the device.The guidewire was observed to be missing a small section of the tip and was not received with the device.The xray was used to verify blood and contrast inside the device.The device was soaked in the ultrasonic bath for a period of 48 hours and was unable to be removed from the device.The complaint was not confirmed for a tip detachment to the microcatheter with no damage and was received fully intact.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that tip detachment, removal difficulty, and extrusion occurred.A direxion hi-flo fathom-16 system was selected for use in a uterine fibroid embolization procedure.The target lesion was reported to be 20% stenosed with mild tortuosity and calcification.While advancing the system within the right uterine artery, resistance was encountered.Imaging appeared to show the fathom wire was double backed up on itself and wrapped around the tip of microcatheter.During wire removal for injection of embolization particles, it was noted that the wire was difficult to remove, and extra tension was applied to pull the wire from the microcatheter.Injection through the microcatheter was completed and embolization was done.During microcatheter removal, higher than normal resistance was encountered.When the microcatheter was removed, it was noted that 3-5 cm from distal tip of the microcatheter had detached.Subsequent angiography revealed that the microcatheter tip was not in the uterine artery.Normal radial pressure was performed, and the patient was discharged without incident.However, several days later, the patient called and reported that she had pulled out what she believed to be a suture from the wrist access site.Upon examination, it was confirmed that it was the tip of the microcatheter used during the case.No further patient complications were reported.
Event or Problem Description
It was reported that tip detachment, removal difficulty, and extrusion occurred.A direxion hi-flo fathom-16 system was selected for use in a uterine fibroid embolization procedure.The target lesion was reported to be 20% stenosed with mild tortuosity and calcification.While advancing the system within the right uterine artery, resistance was encountered.Imaging appeared to show the fathom wire was double backed up on itself and wrapped around the tip of microcatheter.During wire removal for injection of embolization particles, it was noted that the wire was difficult to remove, and extra tension was applied to pull the wire from the microcatheter.Injection through the microcatheter was completed and embolization was done.During microcatheter removal, higher than normal resistance was encountered.When the microcatheter was removed, it was noted that 3-5 cm from distal tip of the microcatheter had detached.Subsequent angiography revealed that the microcatheter tip was not in the uterine artery.Normal radial pressure was performed, and the patient was discharged without incident.However, several days later, the patient called and reported that she had pulled out what she believed to be a suture from the wrist access site.Upon examination, it was confirmed that it was the tip of the microcatheter used during the case.No further patient complications were reported.

• Brand Name: DIREXION HI-FLO FATHOM-16 SYSTEM
• Common Device Name: 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: 19034430
• Report Number: 2124215-2024-15285
• Device Sequence Number: 6992237
• Product Code: KRA
• UDI-Device Identifier: 08714729839729
• UDI-Public: 08714729839729
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/20/2025
• Device Model Number: 84591
• Device Catalogue Number: 84591
• Device Lot Number: 0032474532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female