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

Model Number M001183020

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 05/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the catheter was broken.A renegade hi-flo kit was selected for use.During preparation, the physician flushed the lumen of the device with heparinized saline and made sure there were no leaks.However, when device was removed from the carrier hoop, it was noted that the catheter was broken into two parts.The procedure was completed with another of the same device.No patient complications reported and patient's status was stable.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The hub, shaft and tip were microscopically examined.The device did not show a broken shaft; however, the shaft did show 2 kinks at the distal end of the device.The 1st kink was located approximately 5cm from the tip and the 2nd kink was located approximately 9cm from the tip.The alleged complaint of the broken shaft was not confirmed.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

Event Description

It was reported that the catheter was broken.A renegade hi-flo kit was selected for use.During preparation, the physician flushed the lumen of the device with heparinized saline and made sure there were no leaks.However, when device was removed from the carrier hoop, it was noted that the catheter was broken into two parts.The procedure was completed with another of the same device.No patient complications reported and patient's status was stable.

• Brand Name: RENEGADE¿ HI-FLO¿ KIT
• Type of Device: CATHETER, CONTINUOUS FLUSH
• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6838232
• MDR Text Key: 84635372
• Report Number: 2134265-2017-08756
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K000177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: M001183020
• Device Catalogue Number: 18-302
• Device Lot Number: 0020002093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2016
• 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