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

Model Number	29460
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coating peeled off.The target lesion area was located in the left gastric artery.A 135/20 renegade hi flo kit was selected for use.During the procedure, the microcatheter was advanced into the patient's body, it was noted that the coating of the supporting guidewire peeled off and could not be used.No peeled components were left inside the patient.The procedure was completed with another of same device.No patient complications reported and the patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer.The device was returned for analysis.Returned product consisted of a renegade hi flo microcatheter and the guide wire.The devices were bloody.Analysis of the guide wire, tip, inner/outer shaft and hub/strain relief included microscopic and visual inspection.Inspection revealed the black coating (of wire) was separated 4mm and 12mm from the tip.Inspection of the rest of the device found no other damage or defects.
Event or Problem Description
It was reported that the coating peeled off.The target lesion area was located in the left gastric artery.A 135/20 renegade hi flo kit was selected for use.During the procedure, the microcatheter was advanced into the patient's body, it was noted that the coating of the supporting guidewire peeled off and could not be used.No peeled components were left inside the patient.The procedure was completed with another of same device.No patient complications reported and the patient was stable post procedure.

• Brand Name: RENEGADE HI-FLO KIT
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10396510
• Report Number: 2134265-2020-10905
• Device Sequence Number: 19514721
• Product Code: KRA
• UDI-Device Identifier: 08714729280781
• UDI-Public: 08714729280781
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 09/04/2020

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: 04/09/2021
• Device Model Number: 29460
• Device Catalogue Number: 29460
• Device Lot Number: 0023771624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 09/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 75