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

Model Number 80617

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/27/2019

Event Type  malfunction  

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 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
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8514787
• MDR Text Key: 141975953
• Report Number: 2134265-2019-03829
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729444442
• UDI-Public: 08714729444442
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K023681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2019
• Initial Date FDA Received: 04/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1