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

Model Number M001183030

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the microcatheter became fractured.The target lesion was located in the liver.A renegade hi-flo kit was selected for use.During procedure, it was noted that the mid part of the microcatheter was broken but not broken in several parts.The device was simply pulled out outside the patient.The procedure was completed with another of the same device.No patient complications were reported and patient's status was stable.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The returned product consisted of a renegade hi-flo micro-catheter with a.018 guide wire stuck in the device.Microscopic examination of the hub, shaft and tip were performed.The device was broken/damaged at 44cm from the hub to 46cm distally.The shaft was not completely separated the inner liner was still connected.The device was soaked in a 37c bath for a period of 24hrs to try and loosen the guidewire and remove it.After soaking the device the guidewire could not be removed.The damage on the micro-catheter most likely contributed to the stuck wire.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported that the microcatheter became fractured.The target lesion was located in the liver.A renegade¿ hi-flo¿ kit was selected for use.During procedure, it was noted that the mid part of the microcatheter was broken but not broken in several parts.The device was simply pulled out outside the patient.The procedure was completed with another of the same device.No patient complications were 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: 7137673
• MDR Text Key: 95644462
• Report Number: 2134265-2017-12669
• 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: 12/07/2017

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: 03/28/2019
• Device Model Number: M001183030
• Device Catalogue Number: 18-303
• Device Lot Number: 0020575511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 01/08/2018
• Supplement Dates FDA Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2017
• 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