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

Model Number M001182480

Device Problems Component Missing (2306); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2014

Event Type  malfunction  

Event Description

It was reported that the distal part of the catheter was not fully coated.A 105/3.0/2.5/.021/20 renegade¿ was selected to treat the target lesion.During a bleeding embolization procedure, the device was unable to advance in an unspecified angiographic catheter.It was then noticed that the distal part of the catheter was not fully coated.The procedure was completed with a different device.No patient complications were reported.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual examination was performed on the catheter and no damage was found.A coating confirmation test was carried out to check the presence and integrity of the coating.The presence of coating and coating damage was evident along the coated length.There was no peeling or missing coating.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that the distal part of the catheter was not fully coated.A 105/3.0/2.5/.021/20 renegade was selected to treat the target lesion.During a bleeding embolization procedure, the device was unable to advance in an unspecified angiographic catheter.It was then noticed that the distal part of the catheter was not fully coated.The procedure was completed with a different device.No patient complications were reported.

• 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: 4132540
• MDR Text Key: 18366314
• Report Number: 2134265-2014-05899
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: K020012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/03/2014

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: 02/29/2016
• Device Model Number: M001182480
• Device Catalogue Number: 18-248
• Device Lot Number: 15934562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2014
• Initial Date FDA Received: 10/01/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1