MAUDE Adverse Event Report: ST. JUDE MEDICAL FLEXABILITY¿ ABLATION CATHETER, BI-D, CURVE D-D; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	A701124
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During a premature ventricular contraction, the catheter's handle was leaking during ablation and the generator displayed a high temperature error message.The catheter was exchanged and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
The reported leak and ¿ee¿ error were not able to be confirmed.The tubing was able to be primed and underwent flow testing with no error messages or other functional anomalies noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported leak and error message remains unknown.

• Brand Name: FLEXABILITY¿ ABLATION CATHETER, BI-D, CURVE D-D
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 7642690
• Report Number: 3008452825-2018-00203
• Device Sequence Number: 2413053
• Product Code: OAD
• UDI-Device Identifier: 05415067011107
• UDI-Public: 05415067011107
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P110016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2018

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: 10/31/2019
• Device Model Number: A701124
• Device Catalogue Number: A701124
• Device Lot Number: 5734269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/04/2018
• Supplement Date Received by Manufacturer: 07/11/2018
• Initial Report FDA Received Date: 06/27/2018
• Supplement Report FDA Received Date: 08/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other