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

Model Number	M001184520
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• MDR Report Key: 7748186
• Report Number: 2134265-2018-06922
• Device Sequence Number: 1280132
• Product Code: KRA
• UDI-Device Identifier: 08714729790839
• UDI-Public: 08714729790839
• Combination Product (Y/N): N
• PMA/510(K) Number: K100892
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 11/14/2020
• Device Model Number: M001184520
• Device Lot Number: 21392361
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2018
• Initial Report FDA Received Date: 08/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1