MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RENEGADE STC 18; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	80617
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a renegade stc microcatheter catheter in the hoop.The complaint device arrived in the packaging hoop and could not be removed.A syringe filled with water was attached to the hoop and was flushed.Once the hoop was flushed, the complaint device easily removed from the hoop.Analysis of the tip and shaft consisted of microscopic and visual inspection.Inspection revealed the inner shaft was stretched for 48.5cm with the outer shaft broken in three areas over the stretched area.The first fracture was located 6mm from the strain relief.The complaint device arrived in the packaging hoop and could not be removed.Inspection of the rest of the device found no other damage.
Event or Problem Description
It was reported that catheter tip was broken.A 105/20/straight/1ro renegade stc 18 was selected for use.During preparation, it was noted that the tip was broken and the device was cracked when unpacking.The device was not used within the patient.No patient complications reported.

• Brand Name: RENEGADE STC 18
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8896517
• Report Number: 2134265-2019-09723
• Device Sequence Number: 11139084
• Product Code: DQO
• UDI-Device Identifier: 08714729444381
• UDI-Public: 08714729444381
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K023681
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/15/2019

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: 02/26/2022
• Device Model Number: 80617
• Device Catalogue Number: 80617
• Device Lot Number: 0023561974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 08/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1