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

Model Number M001182510

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/25/2017

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that there was a hole in the catheter shaft.The target lesion was located in the hepatic artery.A 150/10/1 renegade¿ was selected for use.During the procedure, a hole was noted 30cm from the hub of the microcatheter.Leakage was observed while injection of the contrast.No patient complications were reported and the patient status was stable.

• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6645076
• MDR Text Key: 77760157
• Report Number: 2134265-2017-05949
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K020012
• 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: 05/25/2017

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: 02/29/2020
• Device Model Number: M001182510
• Device Catalogue Number: 18-251
• Device Lot Number: 20387378
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2017
• Initial Date FDA Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2017
• 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