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

Model Number	29462
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.
Event or Problem Description
It was reported that contamination occurred.A renegade hi-flo fathom system was selected for use.Upon opening the packaging, it was noted that the aseptic package was not completely sealed, and the sterility of the device was considered compromised.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.Device evaluated by mfr: the returned renegade catheter was inside of a partially open pouch, indicating it was intentionally opened.The pouch was inspected and there were marks all around the pouch from the heat sealer, suggesting it was sealed at one point.No other issues were identified during the product analysis.Product analysis could not confirm the reported incomplete seal.
Event or Problem Description
It was reported that contamination occurred.A renegade hi-flo fathom system was selected for use.Upon opening the packaging, it was noted that the aseptic package was not completely sealed, and the sterility of the device was considered compromised.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.

• 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: 20620323
• Report Number: 2124215-2024-68532
• Device Sequence Number: 7353365
• 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): 12/10/2024

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 Model Number: 29462
• Device Catalogue Number: 29462
• Device Lot Number: 0032704999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2023
• 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 Sex: Unknown