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

Model Number EC1000

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2018

Event Type  malfunction  

Event 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.

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
• Type of Device: ELECTRODE RECORDING CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 7895226
• MDR Text Key: 120978129
• Report Number: 2182269-2018-00116
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 05414734215664
• UDI-Public: 05414734215664
• Combination Product (y/n): N
• PMA/PMN Number: K983456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1