MAUDE Adverse Event Report: THERAPY¿ ABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number IBI-83552

Device Problems Failure to Analyze Signal (1539); Activation, Positioning or Separation Problem (2906)

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

Event Date 08/27/2021

Event Type  malfunction  

Event Description

Related manufacturing ref: 2030404-2021-00056.During a supraventricular tachycardia ablation procedure, a delay occurred.Signal interference was noted on the second electrode of the fixed curve catheter.The fixed curve catheter was exchanged to continue the procedure.When attempting to advance the ablation catheter to the target, a deflection issue occurred which prevented the catheter from reaching the correct location.Another ablation catheter was then used to complete the procedure with no consequences to the patient.

Manufacturer Narrative

Correction: h6.Additional information: d9, g3, h2, h3.One quadripolar, therapy ablation catheter was received for evaluation.The catheter shaft deflected when actuating the steering mechanism and deflected in the correct shape according to specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the deflection issue remains unknown.

• Brand Name: THERAPY¿ ABLATION CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• MDR Report Key: 12395026
• MDR Text Key: 273591711
• Report Number: 2030404-2021-00055
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• PMA/PMN Number: P040042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: IBI-83552
• Device Lot Number: 7386698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2020
• 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
• Treatment: INQUIRY¿ DIAGNOSTIC CATHETER