MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA FLEXABILITY¿ ABLATION CATHETER, UNI-D, CURVE F; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	A701158
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During a premature ventricular contraction ablation procedure a handle leak occurred.While ablating a saline leak was observed from the catheter and a high temperature error was displayed on the generator.The catheter was removed and replaced to continue the procedure.There were no adverse patient consequences.
Additional Manufacturer Narrative
The reported events of a temperature issue and a leak could not be confirmed.The catheter met specifications for electrical and temperature testing, and functioned per requirements during an irrigation flow test with no leaks noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported temperature issue and leak could not be confirmed.

• Brand Name: FLEXABILITY¿ ABLATION CATHETER, UNI-D, CURVE F
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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
• MDR Report Key: 7772905
• Report Number: 3008452825-2018-00268
• Device Sequence Number: 19180333
• Product Code: OAD
• UDI-Device Identifier: 05415067011503
• UDI-Public: 05415067011503
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2018

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: 12/31/2020
• Device Model Number: A701158
• Device Catalogue Number: A701158
• Device Lot Number: 6297208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/17/2018
• Supplement Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 08/10/2018
• Supplement Report FDA Received Date: 08/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1