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

Model Number 29460

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 06/15/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the tip of the device was fractured.The target lesion was located in the liver vessel.A 35/10 renegade hi flo was selected for use.During the preparation, it was noted that the tip of device was fractured.The procedure was completed with another of the same device.There were no complications reported and the patient is stable.

Manufacturer Narrative

E1.Initial reporter facility name: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.The hub and shaft were visually inspected when returned.The renegade device showed no tip damage; however, there was a kink located 134.5cm from the hub as well as a damaged/flattened shaft located at the hub to 120cm from the hub.Inspection of the remainder of the device, apart from the observed damage revealed no damage or irregularities.The complaint was not confirmed for a tip fracture; however, shaft damage was confirmed.

Event Description

It was reported that the tip of the device was fractured.The target lesion was located in the liver vessel.A 35/10 renegade hi flo was selected for use.During the preparation, it was noted that the tip of device was fractured.The procedure was completed with another of the same device.There were no complications reported and the patient is stable.

• 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: 14958442
• MDR Text Key: 304017839
• Report Number: 2134265-2022-07441
• 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,Followup
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2023
• Device Model Number: 29460
• Device Catalogue Number: 29460
• Device Lot Number: 0027936611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2021
• 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: 47 YR
• Patient Sex: Male
• Patient Weight: 71 KG