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

Model Number M001184520

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by manufacture: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that a wire fracture occurred.A renegade¿ hi-flo¿ fathom¿ system was selected for use.During the procedure, the fathom¿wire was used in intervals for approximately 1 hour.Upon withdrawal, it was noticed that the tip of the wire was detached.The tip was left a few cm outside the microcatheter.When pulling back the wire outside the patient, the tip got stuck into the microcatheter and then the whole microcatheter was pulled out of the patient.The microcatheter was then flushed and the 10 cm of the broken off tip flushed out.No patient complications were reported.

• Brand Name: RENEGADE¿ HI-FLO¿ FATHOM¿ SYSTEM
• 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: 7748186
• MDR Text Key: 116051569
• Report Number: 2134265-2018-06922
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 08714729790839
• UDI-Public: 08714729790839
• Combination Product (y/n): N
• PMA/PMN Number: K100892
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/12/2018

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: 11/14/2020
• Device Model Number: M001184520
• Device Lot Number: 21392361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 08/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2017
• 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