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

Model Number	29462
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a part of the catheter peeled off.A renegade hi-flo fathom system was selected for use in the liver.During unpacking, it was noted that a part of it peeled off, not covered by metal coating, which could not be used normally.The procedure was completed with another of the same device.No complications were reported, and patient was stable post procedure.
Event or Problem Description
It was reported that a part of the catheter peeled off.A renegade hi-flo fathom system was selected for use in the liver.During unpacking, it was noted that a part of it peeled off, not covered by metal coating, which could not be used normally.The procedure was completed with another of the same device.No complications were reported, and patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the renegade hi-flo microcatheter was returned to boston scientific for analysis.The device was inspected for any damage or irregularities.The device showed stretching 3cm from the hub.There were multiple bends and kinks located on the catheter shaft.No coating issues were noticed.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The device was not confirmed for coating issues.No other issues were identified during the product analysis.

• 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 CORK LIMITED; 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: 17872834
• Report Number: 2124215-2023-52559
• Device Sequence Number: 12522977
• Product Code: KRA
• UDI-Device Identifier: 08714729790853
• UDI-Public: 08714729790853
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2023

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: 03/01/2026
• Device Model Number: 29462
• Device Catalogue Number: 29462
• Device Lot Number: 0031153058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/15/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2023
• 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
• Patient Age: 49 YR
• Patient Sex: Unknown
• Patient Weight: 72 KG