MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK RENEGADE¿; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number M001182520

Device Problems Kinked (1339); Device Damaged Prior to Use (2284)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4) device evaluated by mfr.: the device was returned with its packaging and tray, inside the hoop.The catheter was then removed from the tray and from the hoop to be inspected.The catheter was found to be broken at 31cm from the hub and the braid is exposed from 31cm to 44cm from the hub.A coating confirmation test was carried out to check the presence and integrity of the coating.The test confirmed the presence of coating and coating damage was evident along the coated length.Excessive force used in attempting to remove the micro catheter from the dispenser coil most likely caused the damage to the coating.There was no peeling or missing coating.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

Reportable based on device analysis completed on 19jan2016.It was reported that shaft kink occurred.A 130/20/1 renegade was selected for use.During unpacking outside the patient, it was noted that the device was already kinked.The device never went inside the patient's body.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed that the shaft was broken.

• Brand Name: RENEGADE¿
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5441913
• MDR Text Key: 38996970
• Report Number: 2134265-2016-00475
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/19/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Model Number: M001182520
• Device Catalogue Number: 18-252
• Device Lot Number: 16612009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2016
• Initial Date FDA Received: 02/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2014
• 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