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

Model Number M001182840

Device Problem Occlusion Within Device (1423)

Patient Problem Thrombus (2101)

Event Date 12/13/2017

Event Type  Injury  

Manufacturer Narrative

It is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr id# 2134265-2017-13102.It was reported that the catheter clotted during the procedure.Two renegade¿ hi-flo¿ microcatheters were used with tandem microspheres and doxorubicin for a transcatheter arterial chemoembolization (tace) treatment procedure of the liver.The tandem was successfully delivered and implanted; however, during treatment, both catheters clotted.The catheters were removed and a different device was used to complete the procedure.Post procedure the patient was normal and ok.

• Brand Name: RENEGADE¿ HI-FLO¿
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7180716
• MDR Text Key: 96932695
• Report Number: 2134265-2017-13101
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• PMA/PMN Number: K000177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M001182840
• Device Catalogue Number: 18-284
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other