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

Model Number	29417
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/07/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a hole in the shaft.A 150/20/1 renegade was selected for use.During preparation, a hole was noted in the outer shaft.No patient complications were reported.

• 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: 7837897
• Report Number: 2134265-2018-60606
• Device Sequence Number: 1517462
• Product Code: KRA
• UDI-Device Identifier: 08714729322832
• UDI-Public: 08714729322832
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K973645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/31/2018

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: 05/07/2021
• Device Model Number: 29417
• Device Catalogue Number: 29417
• Device Lot Number: 0022218548
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 08/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1