MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE¿ VELOCITY¿ SYSTEM DISPOSABLE PRODUCT, ENSITE¿ ARRAY¿ CATHETER; CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY

Model Number	EC1000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During an ablation procedure, when the catheter was inflated, a leak was noted in the balloon.The tear was confirmed via x-ray and the balloon appeared deflated.The array catheter was not deflated completely so it could hold its balloon inflated enough to execute the procedure and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
The reported leak could not be confirmed.The array was brought to its high profile position, inflated with a saline solution with no leaks or other anomalies noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported leak remains unknown.

• Brand Name: ENSITE¿ VELOCITY¿ SYSTEM DISPOSABLE PRODUCT, ENSITE¿ ARRAY¿ CATHETER
• Common Device Name: CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 8170904
• Report Number: 2182269-2018-00145
• Device Sequence Number: 11122172
• Product Code: MTD
• UDI-Device Identifier: 05414734215664
• UDI-Public: 05414734215664
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K983456
• 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): 01/25/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: EC1000
• Device Lot Number: 6031494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/26/2018
• Supplement Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 01/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1