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

Model Number	29462
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter rupture occurred.A renegade hi-flo catheter was selected for use and during manual injection of contrast medium via a non bsc syringe the catheter ruptured.No patient complications were reported and the procedure was completed via an alternative method.
Event or Problem Description
It was reported that a catheter rupture occurred.A renegade hi-flo catheter was selected for use and during manual injection of contrast medium via a non bsc syringe the catheter ruptured.No patient complications were reported and the procedure was completed via an alternative method.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.The device showed damage in the form of a kink and a twist/kink.The kink was located 22.3cm from the hub and the twisted kink was located 10cm from the tip.Per the customers complaint it was stated that the catheter shaft ruptured during manual injection of contrast medium.A manual syringe of fluid was injected through the catheter.The twisted kink area did show a leak.Inspection of the remainder of the device, 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: 7934929
• Report Number: 2134265-2018-61599
• Device Sequence Number: 13688142
• Product Code: KRA
• UDI-Device Identifier: 08714729790877
• UDI-Public: 08714729790877
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• 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: 04/24/2021
• Device Model Number: 29462
• Device Catalogue Number: 29462
• Device Lot Number: 0022037434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Initial Date Received by Manufacturer: 09/13/2018
• Supplement Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 10/04/2018
• Supplement 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