MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RENEGADE; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	29417
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the coating flaked off the device.A 150cm renegade was selected for an embolization procedure in the splenic artery.During insertion of the renegade through the 5fr non-boston scientific catheter hub, the coating from the distal end of the renegade flaked off outside the patient.A new 150cm renegade was used and the same issue occurred.The procedure was successfully completed with another catheter.There were no patient complications and the patient was fine.
Event or Problem Description
It was reported the coating flaked off the device.A 150cm renegade was selected for an embolization procedure in the splenic artery.During insertion of the renegade through the 5fr non-boston scientific catheter hub, the coating from the distal end of the renegade flaked off outside the patient.A new 150cm renegade was used and the same issue occurred.The procedure was successfully completed with another catheter.There were no patient complications and the patient was fine.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the renegade was returned for analysis.The hub, shaft and tip were visually and microscopically examined.Visual examination of the device showed a kink located 100cm from the hub.Microscopic analysis found that the coating was rolled and bunched up at 99.5cm and at 102cm from the hub.The outer diameter of the renegade was measured and was within specification.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

• Brand Name: RENEGADE
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10819934
• Report Number: 2134265-2020-15649
• Device Sequence Number: 13928656
• Product Code: KRA
• UDI-Device Identifier: 08714729235118
• UDI-Public: 08714729235118
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K973645
• 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): 12/18/2020

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: 06/06/2023
• Device Model Number: 29417
• Device Catalogue Number: 29417
• Device Lot Number: 0025677257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 12/18/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CORDIS C1 5F 65CM; CORDIS C1 5F 65CM