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

Model Number	29462
Medical Device Problem Codes	Break (1069); Difficult to Open or Remove Packaging Material (2922); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(6).
Event or Problem Description
It was reported that the blue coating of the device was separated.A 180cm renegade hi-flo fathom system catheter was selected for use.During preparation, the product could not be withdrawn from the protective carrier hoop and it was found out that the blue coating of the device had separated.The procedure was completed with another of same device.No patient complications were reported.
Event or Problem Description
It was reported that the blue coating of the device was separated.A 180cm renegade hi-flo fathom system catheter was selected for use.During preparation, the product could not be withdrawn from the protective carrier hoop and it was found out that the blue coating of the device had separated.The procedure was completed with another of same device.No patient complications were reported.Device evaluated by manufacturer: returned product consisted of a renegade hi-flo micro-catheter in the carrier tube.The hub, shaft and tip were microscopically examined.This device showed damage consisting of 1 fracture on the shaft.The fracture was located 5cm from the hub.The shaft was not completely separated the inner liner was still connected.The fracture that was noticed on the device are consistent with the device being removed from the shipping tube without being completely hydrated with saline.The device was attempted to be pulled from the carrier tube and it was difficult to remove.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.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Initial reporter fax: (b)(6).Device code 2978 was corrected to 1069 and 2922.This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/13/2018 04:12 pm ct.The report number is being corrected from: 2134265-2018-64152to: 2134265-2018-62917.

• Brand Name: RENEGADE HI-FLO FATHOM SYSTEM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8074824
• Report Number: 2134265-2018-62917
• Device Sequence Number: 13931589
• Product Code: KRA
• UDI-Device Identifier: 08714729790860
• UDI-Public: 08714729790860
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K140329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2019

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: 07/11/2021
• Device Model Number: 29462
• Device Catalogue Number: 29462
• Device Lot Number: 0022368433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Initial Date Received by Manufacturer: 10/31/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1