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 Consequences Or Impact To Patient (2199)
Date of Event	09/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter fracture occurred.The target lesion was located in right iliac artery.A 150/30 renegade stc-18 was selected for use in abdominal aortic aneurysm.During unpacking, it was noted that the catheter was fractured.The catheter surface was flushed and the carrier tube was hydrated a few seconds prior to removing the device from the carrier tube.There was no resistance felt during removal of the catheter from the carrier tube.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of a renegade stc catheter in two pieces.The device was returned in the hoop.The hoop was flushed in order to remove the device for analysis.Analysis of the tip and shaft included microscopic and visual inspection.Inspection revealed a complete shaft separation located 45.4cm from the strain relief.Inspection of the rest of the device found no other damage or irregularities.The reported fracture was confirmed.
Event or Problem Description
It was reported that catheter fracture occurred.The target lesion was located in right iliac artery.A 150/30 renegade stc-18 was selected for use in abdominal aortic aneurysm.During unpacking, it was noted that the catheter was fractured.The catheter surface was flushed and the carrier tube was hydrated a few seconds prior to removing the device from the carrier tube.There was no resistance felt during removal of the catheter from the carrier tube.The procedure was completed with another of the same device.No patient complications were 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: 9152010
• Report Number: 2134265-2019-11919
• Device Sequence Number: 11414868
• Product Code: DQO
• UDI-Device Identifier: 08714729444510
• UDI-Public: 08714729444510
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K023681
• 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): 11/21/2019

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: 08/14/2021
• Device Model Number: 80617
• Device Catalogue Number: 80617
• Device Lot Number: 0022652937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Initial Date Received by Manufacturer: 09/16/2019
• Supplement Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 11/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 40