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

Model Number	29420
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The device was inspected for any damage or irregularities.The renegade hi flo had multiple kinks and stretching along the length of the shaft.At 122.2 cm from the hub flattening of the catheter was confirmed.The tip had damage in the form of a detachment of a piece approx.1mm from the tip.The piece was not returned.Review of the product specification indicates the renegade hi-flo is compatible with a 5fr angiographic catheter with an id of.042id.The reported information indicates the renegade was used with 4fr angiographic catheter which is not compatible with the renegade hi-flo, therefore, there is an indication of a compatibility issue.
Event or Problem Description
Reportable based on device investigation completed on 01aug2022.It was reported that a micro-catheter was stuck.A 135/20 renegade hi-flo selected for use in a percutaneous selective arterial embolization in the liver.During advancement, the device was stuck into the 4f image catheter.The procedure was completed with a different device.No complications reported and the patient is stable.However, the device investigation revealed a piece of the tip (approximately 1mm) detached and not returned.

• 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: 15289278
• Report Number: 2134265-2022-08359
• Device Sequence Number: 20617711
• Product Code: KRA
• UDI-Device Identifier: 08714729280644
• UDI-Public: 08714729280644
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/24/2022

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: 11/02/2024
• Device Model Number: 29420
• Device Catalogue Number: 29420
• Device Lot Number: 0028492888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2021
• 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
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 66 KG