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

Model Number	29417
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter broke.A 150/20/1tip renegade was selected for use in a percutaneous transluminal angioplasty (pta) procedure.During unpacking, the distal part of the catheter broke.The procedure was completed with another renegade device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a renegade microcatheter inside the hoop.The hoop needed to be flushed in order to remove the complaint device.Analysis of the tip, shaft and hub/strain relief included microscopic and visual inspection.The ends of the outer shaft separation had stress marks in the material, indicating excessive tensile force was put upon the shaft.The inner shaft was stretched taught, also indicative of excessive tensile force.Inspection revealed a complete separation both the inner and outer shaft located 12mm from the strain relief, with the inner shaft stretched for a length 32.5cm.Inspection of the rest of the device found no other damage to the device.
Event or Problem Description
It was reported that the catheter broke.A 150/20/1tip renegade was selected for use in a percutaneous transluminal angioplasty (pta) procedure.During unpacking, the distal part of the catheter broke.The procedure was completed with another renegade device.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: 8921933
• Report Number: 2134265-2019-10057
• Device Sequence Number: 2295437
• Product Code: KRA
• UDI-Device Identifier: 08714729322832
• UDI-Public: 08714729322832
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K020012
• 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): 09/24/2019

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: 10/15/2021
• Device Model Number: 29417
• Device Catalogue Number: 29417
• Device Lot Number: 0022943480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Initial Date Received by Manufacturer: 08/15/2019
• Supplement Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 09/24/2019
• Patient Sequence Number: 1