MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA VIEWFLEX¿ XTRA ICE CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number D087031

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2019

Event Type  malfunction  

Manufacturer Narrative

One viewflex xtra ice catheter was received for complaint evaluation.Visual inspection revealed a fracture in the shaft 0.5¿ proximal to the distal tip with exposed wires.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the fracture is due to damage during use.

Event Description

This report is to advise of an event observed during analysis confirming fracture in the shaft of the catheter.

• Brand Name: VIEWFLEX¿ XTRA ICE CATHETER
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8550958
• MDR Text Key: 143421455
• Report Number: 3008452825-2019-00215
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 05415067002082
• UDI-Public: 05415067002082
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133853
• 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: 04/25/2019

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: 09/30/2019
• Device Model Number: D087031
• Device Lot Number: 6687696
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/24/2019
• Initial Date FDA Received: 04/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2018
• 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