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

Model Number	29462
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr: the product was returned to boston scientific for analysis.The returned product consisted only of the renegade hi-flo micro-catheter system fathom 16 guidewire.Inspection of the guidewire revealed a detached/separated tip, and the missing piece of the tip was not received.No other issues were identified during the product analysis.Analysis determined the clinical observation was confirmed for a detached/separated guidewire tip.
Event or Problem Description
It was reported that tip detachment occurred and remained inside the patient.A 180cm renegade hi-flo fathom system was selected for use in a hepatic hemorrhagic embolization of the right hepatic artery.After repositioning the microcatheter and guidewire, near the end of the procedure, fluoroscopy revealed a radiopaque black object.After a visual inspection, the guidewire was incomplete, and the artifact previously observed via fluoroscopy corresponded to a 10cm segment of the guidewire which had embolized to a right hepatic branch.It was noted that the embolized device fragment was serving as an embolization material and its retrieval was not needed as it was helping to ensure no recanalization of bleeding would be needed on the embolized branches.Radiographic images confirmed that the object could not be removed; therefore, it remained in the patient.The physician indicated that the object did not present harm to the patient.The procedure was completed, and no patient complications were reported.The patient was transferred to the intensive care unit and consequently to an oncology ward for continued care.

• Brand Name: RENEGADE HI-FLO FATHOM 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: 19205619
• Report Number: 2124215-2024-21724
• Device Sequence Number: 8142334
• Product Code: KRA
• UDI-Device Identifier: 08714729790877
• UDI-Public: 08714729790877
• Combination Product (Y/N): N
• PMA/510(K) Number: K140329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/29/2024

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 Model Number: 29462
• Device Catalogue Number: 29462
• Device Lot Number: 0032714282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2023
• 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 Age: 52 YR
• Patient Sex: Female