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

Model Number	80617
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 03-dec-2018.A renegade stc 18 was selected for an embolization procedure in the severely tortuous and moderately calcified internal iliac artery.However, the device was unable to be advanced to the lesion.The procedure was completed with a different device.There were no patient complications.However, device analysis found the shaft was separated.Device eval by manufacturer: returned product consisted of a renegade stc-18 micro-catheter.The hub, shaft and tip were microscopically examined.Under microscopic evaluation it was noticed that the device looked to be cut/detached/separated at the tip area.The device was measured and there was approximately 16cm of the device missing from the tip end.The device should measure 130cm long.The actual measured device was 114cm.Inspection of the remainder of the device, revealed no other damage or irregularities.A.014 thruway test guidewire was inserted into the device and the wire transcended through the lumen with no hesitations or restrictions.

• 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: 8164480
• Report Number: 2134265-2018-64268
• Device Sequence Number: 11307444
• Product Code: DQO
• UDI-Device Identifier: 08714729444466
• UDI-Public: 08714729444466
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Report Date (Section B): 12/14/2018

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: 03/05/2021
• Device Model Number: 80617
• Device Catalogue Number: 80617
• Device Lot Number: 0021950601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 12/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR