MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK RENEGADE¿; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number M001182510

Device Problems Entrapment of Device (1212); Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device was returned for evaluation.A visual examination was performed on the catheter and a break in the shaft was found at 27 cm from the hub.The braid was exposed from 27 cm from the hub up to 42.4 cm from the hub.The catheter shaft was also found stretched from 18 cm from the hub up to 27 cm from the hub and from 42 cm from the hub up to 45 cm from the hub.A coating confirmation test was carried out to check the presence and integrity of the coating.The test confirmed the presence of coating and coating damage was evident along the coated length.There was no peeling or missing coating.No other defects were noted.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

Reportable based on product analysis completed on 18 nov 2015.It was reported that the device would not come out of the hoop and it became unbraided.A renegade was selected treat an unspecified target lesion.During preparation for a procedure, the tech flushed the catheter and noticed that the catheter would not come out of the hoop that it's packaged in and it became unbraided.The procedure was completed with another device.No patient complications reported.However device analysis revealed a break in the shaft was at 27 cm from the hub.

• Brand Name: RENEGADE¿
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5297215
• MDR Text Key: 33479933
• Report Number: 2134265-2015-08863
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: M001182510
• Device Catalogue Number: 18-251
• Other Device ID Number: 18138496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2015
• 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