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	08/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the outer sheath was flaking.A 180cm renegade hi-flo fathom system was selected for use.During preparation, when the physician unpacked and flushed the device, it was noted that the outer sheath flaking.The procedure was completed with another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that the outer sheath was flaking.A 180cm renegade hi-flo fathom system was selected for use.During preparation, when the physician unpacked and flushed the device, it was noted that the outer sheath flaking.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The device was inspected for any damage or irregularities.The device showed damage in the form of stretching and fractures located 4.2cm, 28cm and 63.5cm from the hub.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The device was confirmed for stretching and fractures.

• Brand Name: RENEGADE HI-FLO FATHOM SYSTEM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15294301
• Report Number: 2124215-2022-31936
• Device Sequence Number: 16822046
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2022

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: 05/05/2025
• Device Model Number: 29462
• Device Catalogue Number: 29462
• Device Lot Number: 0029350768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2022
• Supplement Date Received by Manufacturer: 09/15/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2022
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 78 KG