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

Model Number	29460
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter fracture occurred.A renegade hi-flo kit was selected for use in the liver.During unpacking, the catheter surface was flushed/ carrier tube was hydrated prior to removal from carrier hoop for 5 minutes.A resistance was felt during catheter removal and re-flushing with saline was done.However, it was noted that the proximal end was fractured and could not be used anymore.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 catheter fracture occurred.A renegade hi-flo kit was selected for use in the liver.During unpacking, the catheter surface was flushed/ carrier tube was hydrated prior to removal from carrier hoop for 5 minutes.A resistance was felt during catheter removal and re-flushing with saline was done.However, it was noted that the proximal end was fractured and could not be used anymore.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 and a fracture located 6.4cm from the hub.There were 2 kinks on the device located 123cm and 131.4cm from the hub.The device was not completely separated, the inner liner was still attached.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.No other issues were identified during the product analysis.

• Brand Name: RENEGADE HI-FLO KIT
• 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: 17749320
• Report Number: 2124215-2023-47689
• Device Sequence Number: 4184661
• Product Code: KRA
• UDI-Device Identifier: 08714729280774
• UDI-Public: 08714729280774
• 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): 10/16/2023

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: 06/28/2024
• Device Model Number: 29460
• Device Catalogue Number: 29460
• Device Lot Number: 0029854395
• 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: 08/23/2023
• Supplement Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2022
• 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: 47 YR
• Patient Sex: Male
• Patient Weight: 68 KG