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

Model Number	29462
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the sheathing started coming off on the catheter.A renegade hi-flo fathom system was selected for a thrombectomy procedure of the liver.During the procedure, it was noted that the sheathing started stripping off of the catheter.The device was simply removed over the wire.No device fragments were left inside of the patient's body.The procedure was completed with another of the same device.No complications were reported and the patient's condition was stable.
Additional Manufacturer Narrative
E1- initial reporter address 1: (b)(6).Device evaluated by mfr: the device was returned for analysis.Returned product consisted of a renegade hi-flo microcatheter, with the guide wire loaded in the shaft of the device.The guide wire was removed from the shaft after lab analysis was completed.Analysis of the tip, and inner/outer shaft included microscopic and visual inspection.Inspection revealed the outer shaft was separated 42cm from the strain relief, and the inner shaft was stretched in between the outer fractures.Inspection of the remainder of the device, apart from the damage observed revealed no other damage or irregularities.The guide wire was removed from the shaft at the end of the lab analysis.The wire had been stuck in the sheath, so a syringe (filled with water) was used to flush the renegade device.After many attempts to flush the shaft, the guide wire became loose enough to remove from the renegade shaft.
Event or Problem Description
It was reported that the sheathing started coming off on the catheter.A renegade hi-flo fathom system was selected for a thrombectomy procedure of the liver.During the procedure, it was noted that the sheathing started stripping off of the catheter.The device was simply removed over the wire.No device fragments were left inside of the patient's body.The procedure was completed with another of the same device.No complications were reported and the patient's condition was stable.

• 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: 9105432
• Report Number: 2134265-2019-11533
• Device Sequence Number: 2138716
• Product Code: KRA
• UDI-Device Identifier: 08714729790884
• UDI-Public: 08714729790884
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K140329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2019

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: 05/26/2022
• Device Model Number: 29462
• Device Catalogue Number: 29462
• Device Lot Number: 0023855199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1