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

Model Number	29460
Medical Device Problem Codes	Entrapment of Device (1212); Material Integrity Problem (2978); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire entrapment occurred.A 135/10 renegade hi-flo kit was selected for use in a right hepatic artery.During the procedure, it was noted that the guidewire was stuck.When the microcatheter was withdrawn, a mark of being kinked was noted at the tip of the microcatheter.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.
Additional Manufacturer Narrative
H6 - device codes: corrected to 'entrapment of device' from 'positioning problem' device evaluated by mfr: the device was returned for evaluation.Inspection of the device revealed two slight shaft kinks.A guidewire insertion test was performed.The complaint was not confirmed for any advancing issues; however, there was damage that could have contributed to the reported complaint event.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that guidewire entrapment occurred.A 135/10 renegade hi-flo kit was selected for use in a right hepatic artery.During the procedure, it was noted that the guidewire was stuck.When the microcatheter was withdrawn, a mark of being kinked was noted at the tip of the microcatheter.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.Product analysis completed on 22may2024.Returned product consisted of a renegade hi-flo micro-catheter.Inspection of the device revealed two slight shaft kinks.A guidewire insertion test was performed.The complaint was not confirmed for any advancing issues; however, there was damage that could have contributed to the reported complaint event.No other issues were identified with the device and no patient complications were reported.

• 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 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: 19093377
• Report Number: 2124215-2024-18569
• Device Sequence Number: 12687464
• 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): 06/12/2024

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 Expiration Date: 07/11/2025
• Device Model Number: 29460
• Device Catalogue Number: 29460
• Device Lot Number: 0032202760
• 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: 03/19/2024
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2023
• 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: 44 YR
• Patient Sex: Male
• Patient Weight: 68 KG