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

Model Number	29420
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	Vasoconstriction (2126)
Date of Event	08/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter address (b)(6).Initial reporter city(b)(6).
Event or Problem Description
It was reported that vasospasm occurred.A 135/10 renegade hi-flo was used to select branch small vessels during tace procedure for interventional treatment and was used for cross circuity narrow blood vessels.During the procedure, it was noted that due to the uneven diameter and thickness of microcatheter that did not reach the specified parameters, the device could not cross the non-boston scientific 4f catheter.Hence, the physician could only use the 4f catheter in the remote operation which led to the increased risk of complications of the procedure.The device was directly removed and the procedure was completed with a different device.Vasospasm occurred that led to an increased risk of complications of the procedure.
Additional Manufacturer Narrative
E1.Initial reporter address 1-no.1 (b)(6).E1.Initial reporter city-(b)(6).
Event or Problem Description
It was reported that vasospasm occurred.A 135/10 renegade hi-flo was used to select branch small vessels during tace procedure for interventional treatment and was used for cross circuity narrow blood vessels.During the procedure, it was noted that due to the uneven diameter and thickness of microcatheter that did not reach the specified parameters, the device could not cross the non-boston scientific 4f catheter.Hence, the physician could only use the 4f catheter in the remote operation which led to the increased risk of complications of the procedure.The device was directly removed and the procedure was completed with a different device.Vasospasm occurred that led to an increased risk of complications of the procedure.It was further reported that diluted lidocaine was provided to treat vasospasm.

• Brand Name: RENEGADE HI-FLO
• 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: 15446972
• Report Number: 2124215-2022-32969
• Device Sequence Number: 14608098
• Product Code: KRA
• UDI-Device Identifier: 08714729280637
• UDI-Public: 08714729280637
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/20/2024
• Device Model Number: 29420
• Device Catalogue Number: 29420
• Device Lot Number: 0028592862
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/25/2022
• Supplement Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 4F ANGIOGRAPHIC MICROCATHETER; 4F ANGIOGRAPHIC MICROCATHETER
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Male