MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE¿ VELOCITY¿ SYSTEM DISPOSABLE PRODUCT, ENSITE¿ ARRAY¿ CATHETER; ELECTRODE RECORDING CATHETER

Model Number	EC1000
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During a right ventricular outflow tract ablation, the expired catheter would not display a signal.The catheter was replaced and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
The catheter was connected to an arraylink and velocity system with wet lab.The catheter was validated and no functional anomalies were noted.The fly eye charts were good except for one bad electrode.The array catheter ifu, artmt100136324 rev.A states ¿catheters may be marketed and considered functional with up to 8 inactive electrodes.The investigation also confirmed the device was used past its expiration date.The array catheter ifu, artmt100136324 rev.A states ¿use prior to the ¿use before¿ date printed on the packaging label.¿ the device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported signal issue remains unknown.The cause of the using the product past its expiration date is consistent with user error.

• Brand Name: ENSITE¿ VELOCITY¿ SYSTEM DISPOSABLE PRODUCT, ENSITE¿ ARRAY¿ CATHETER
• Common Device Name: ELECTRODE RECORDING CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 7895226
• Report Number: 2182269-2018-00116
• Device Sequence Number: 13908092
• Product Code: MTD
• UDI-Device Identifier: 05414734215664
• UDI-Public: 05414734215664
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 11/08/2018

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: 07/31/2018
• Device Model Number: EC1000
• Device Lot Number: 5621798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/02/2018
• Supplement Date Received by Manufacturer: 09/23/2018; 11/07/2018
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 10/12/2018; 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1