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

Model Number	80617
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of a renegade stc-18 micro-catheter.The device showed damage at the distal end from the tip proximal 14cm.The shaft looked flattened in some areas as well as some delaminating of the outside shaft.The device was very sticky and stuck together at the distal end.The shaft showed a kink located at 62.7cm from the hub.A.014 guidewire was attempted to be put through the distal tip; however, the damage would not allow the wire to transcend through the device.Inspection of the remainder of the device, except for the damage observed revealed no other damage or irregularities.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2019.It was reported that the fathom wire would pass through the catheter.A 130/20 renegade stc 18 was selected for use.During the procedure, it was noted that the fathom wire would not pass thorough tapered tip of the renegade catheter.Subsequently, the device was removed through the introducer sheath and no damage was noted on the fathom wire.The procedure was completed with another of the same device.No patient complications were reported and the patient was fine.However, device analysis revealed delamination of the outer shaft.

• 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: 8514787
• Report Number: 2134265-2019-03829
• Device Sequence Number: 11130620
• Product Code: DQO
• UDI-Device Identifier: 08714729444442
• UDI-Public: 08714729444442
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 04/15/2019

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: 04/30/2019
• Device Model Number: 80617
• Device Catalogue Number: 80617
• Device Lot Number: 19308993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 04/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1