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	08/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter coating peeled off.The patient underwent a pulmonary embolism due to pulmonary hemorrhage.The target lesion was located in the pulmonary artery.A renegade hi-flo fathom system was selected for use.Upon unpacking, it was found that the hydrophilic coating of the microcatheter kit peeled off.The device was not used on the patient and was replaced for another of the same device to complete the procedure.No complications reported, and patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.A visual inspection revealed a shaft fracture and stretching inside the carrier hoop.A microscope inspection confirmed the fractured/stretched shaft was located at 2.8cm to 6cm from the strain relief.The complaint was confirmed for issues due to shaft damage.
Event or Problem Description
It was reported that the catheter coating peeled off.The patient underwent a pulmonary embolism due to pulmonary hemorrhage.The target lesion was located in the pulmonary artery.A renegade hi-flo fathom system was selected for use.Upon unpacking, it was found that the hydrophilic coating of the microcatheter kit peeled off.The device was not used on the patient and was replaced for another of the same device to complete the procedure.No complications reported, and patient status was stable.

• 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: 20005365
• Report Number: 2124215-2024-49393
• Device Sequence Number: 7067042
• 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): 10/03/2024

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: 0032714217
• 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: 08/01/2024
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 10/03/2024
• 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
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 58 KG