MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE¿ X AMPERE CONNECT CABLE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number ENSITE-ACBL-60-01

Device Problem Signal Artifact/Noise (1036)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2024

Event Type  malfunction  

Event Description

During the wolfe parkinson white procedure, noise was noted causing a delay.When the ablation catheter was inserted into the patient¿s right atrium, electrode 2 was noted to be off the ensite x screen and not visualized appropriately.Electrode 2 of the ampere connect cable was not displaying properly.There were no egms on the non-abbott (cardiolab) system.All connections from the catheter to the tactisys, and tactisys to the generator were reseated.The tactisys, tactiflex rf cable and catheter were replaced, which did not resolve the issue.The ampere connect cable was replaced to continue the procedure with no consequences to the patient.

Manufacturer Narrative

One ensite x to ampere cable (acbl) was received for evaluation.Visual inspection revealed the ports and labels were free of physical damage.No nicks or cuts along the cabling¿s outer sheath were noted.The cable (acbl) was evaluated using pin to pin resistance testing.All pins/channels were successful and stable continuity was established.The reported event was not duplicated by pin-to-pin resistance testing.Based on the investigation and information provided to abbott, the reported noise and subsequent delay remains unknown.

• Brand Name: ENSITE¿ X AMPERE CONNECT CABLE
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18529412
• MDR Text Key: 333098091
• Report Number: 2184149-2024-00015
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K231415
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2024

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
• Device Operator: Health Professional
• Device Model Number: ENSITE-ACBL-60-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/12/2024
• Initial Date FDA Received: 01/17/2024
• Supplement Dates Manufacturer Received: 01/19/2024
• Supplement Dates FDA Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1