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

Model Number	29462
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 18oct2018.It was reported that the tip was kinked and damaged.A 180cm/150cm renegade hi-flo fathom system was selected for use.During preparation, it was noted that the device was not on its original shape; tip of the device was kinked and bent in different directions.It was like somebody had it in his hand and deformed it completely, only at its tip.The procedure was completed with a different device.No patient complications were reported.However, device analysis revealed multiple fractures.It was confirmed that the device was all in that way (fractured) when opening the package during preparation.Device evaluated by mfr: the device was returned for analysis.Returned product consisted of a renegade hi-flo micro-catheter.The hub, shaft and tip were microscopically examined.This device was severely damaged.The device was fractured in 3 locations.The locations of the fractures were 12.4cm, 22.5cm and 37.5cm from the hub.The shaft was not completely separated the inner liner was still connected.There were multiple kinks throughout the length of the catheter shaft.The catheter shaft showed that it had been stretched.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.

• 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: 8047044
• Report Number: 2134265-2018-62657
• Device Sequence Number: 1484468
• Product Code: KRA
• UDI-Device Identifier: 08714729790884
• UDI-Public: 08714729790884
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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
• Report Date (Section B): 11/07/2018

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: 05/18/2021
• Device Model Number: 29462
• Device Catalogue Number: 29462
• Device Lot Number: 0022141069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 11/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1