MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE¿ X EP SYSTEM CATHETER CONNECTOR CABLE; ADVISOR SE 22 PIN ENSITE X CABLE; CABLE, ELECTRODE

Model Number D-ENS-AVSE-6-CBL

Device Problem Thermal Decomposition of Device (1071)

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

Event Type  malfunction  

Event Description

The extension cable was delivered for sterilization and charring was noted at the connection port of the cable.A new cable was tested, washed and resterilized without issue.

Manufacturer Narrative

Additional information:d9, g3, h2, h3 one 22-pin advisor se, ensite x diagnostic catheter cables were received for evaluation.The connector plug insert appeared normal, no visual anomalies or char were noted.The cause of the reported ¿charring¿ at the connection port remains unknown.

• Brand Name: ENSITE¿ X EP SYSTEM CATHETER CONNECTOR CABLE; ADVISOR SE 22 PIN ENSITE X CABLE
• Type of Device: CABLE, ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12820945
• MDR Text Key: 281937820
• Report Number: 3005334138-2021-00704
• Device Sequence Number: 1
• Product Code: IKD
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K172393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: D-ENS-AVSE-6-CBL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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