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

Model Number 29460

Device Problem Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/08/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The hub and shaft were visually inspected when returned.The renegade device severe buckling located from the hub to 36cm proximal.There was a fracture 36.5cm from the hub.The renegade devices product specification states the proximal od should be.0038+.0013 -.0026.The proximal end of the renegade that was returned was checked using a laser micrometer and measured.0386 which is in specification per the document.The distal end of the shaft measurement should be.0367+.0013 -.0026 and this device measured.0412 at the bond area of the shaft.The product must be compatible with (pass through uninhibitedly) 0.038" (0.97 mm) guidewire compatible guiding catheters (0.042" (1.1 mm) inside diameter).The device could not be inserted into an 5fr angiographic test catheter due to the severe damage on the shaft.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The complaint was not confirmed for advancing issues; however, severe shaft damage was confirmed.

Event Description

Reportable based on device analysis completed on 27sep2022.It was reported that the microcatheter could not be advance in the lesion.The target lesion was located in the liver.A 135/10 renegade hi flo kit catheter infusion was selected for use.During the procedure, the microcatheter was advanced through the catheter, however, it could not be advanced in the lesion.The catheter was replaced with a non-bsc 5frh catheter, but the microcatheter could not be advanced as well.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 was fractured at 36.5ccm from the hub.

• Brand Name: RENEGADE HI-FLO KIT
• Type of Device: 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: 15629744
• MDR Text Key: 306432875
• Report Number: 2124215-2022-40481
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 08714729280774
• UDI-Public: 08714729280774
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K140329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2023
• Device Model Number: 29460
• Device Catalogue Number: 29460
• Device Lot Number: 0027190727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 65 KG