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

Model Number	29462
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 29nov2022.It was reported that the microcatheter could not cross the imaging catheter and was kinked.The target lesion was located in the liver.A 180cm renegade hi-flo 16 was selected for use.During the procedure, it was noted that the microcatheter set could not cross the imaging catheter.After several attempts, the device got kinked, therefore, it could not be used.The procedure was completed with another of the same device.There were no complications reported and the patient was stable post procedure.However, device analysis revealed that the device fractured 40.5cm from the hub.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The hub and shaft were visually inspected when returned.The renegade device showed multiple small bends and kinks.The device showed stretching and a fracture located 40.5cm from the hub.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The advancing issues could not be confirmed due to the damage on the catheter shaft.The complaint was confirmed for shaft damage.

• 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: 15981141
• Report Number: 2124215-2022-51209
• Device Sequence Number: 12236280
• 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
• Report Date (Section B): 12/14/2022

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: 05/19/2025
• Device Model Number: 29462
• Device Catalogue Number: 29462
• Device Lot Number: 0029437873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2022
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 70 KG