MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC INQUIRY¿ OPTIMA¿ DIAGNOSTIC CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number IBI-81600

Device Problems Device Dislodged or Dislocated (2923); Material Deformation (2976)

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

Event Date 09/21/2021

Event Type  malfunction  

Event Description

During an atrial fibrillation procedure, electrode 13 was displaced.The catheter was replaced and the procedure was completed with no adverse consequences to the patient.

Manufacturer Narrative

One duodecapolar, spiral loop, inquiry optima diagnostic catheter was received for evaluation.Electrode 13 was not displaced as initially reported.Dissection revealed conductor wire 13 had been fractured proximal to the weld joint.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the fractured conductor wire 13 remains unknown.

• Brand Name: INQUIRY¿ OPTIMA¿ DIAGNOSTIC CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC; 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12546946
• MDR Text Key: 273784480
• Report Number: 2030404-2021-00065
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K042775
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: IBI-81600
• Device Lot Number: 7834222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1