MAUDE Adverse Event Report: ST. JUDE MEDICAL FLEXABILITY¿ ABLATION CATHETER, BI-D, CURVE F-J; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	A701128
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One flexibility¿ ablation catheter, bi-d, curve f-j was returned due to a steering issue.The catheter deflected when actuating the steering mechanism and the curve dimensions met specifications; however, the catheter was out of plane due to a cut in the shaft proximal to electrode 2.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported steering issue is due to the cut in the shaft of the catheter.The cause of the cut in the shaft remains unknown.
Event or Problem Description
This report is to advise of an incidental finding of catheter shaft damage, exposing internal components observed during analysis.

• Brand Name: FLEXABILITY¿ ABLATION CATHETER, BI-D, CURVE F-J
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 8682853
• Report Number: 3008452825-2019-00266
• Device Sequence Number: 2260643
• Product Code: OAD
• UDI-Device Identifier: 05415067011145
• UDI-Public: 05415067011145
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P110016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/10/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: A701128
• Device Catalogue Number: A701128
• Device Lot Number: 6581085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 06/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 88