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

Model Number IBI-83459

Device Problem Fracture (1260)

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

Event Date 08/16/2022

Event Type  malfunction  

Event Description

During the psvt procedure, it was noted that the catheter presented a crack in the mesh, outside of the catheter after the electrodes, after it was inserted into the patient.The catheter was replaced and the procedure was completed with no adverse consequences to the patient.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported crack could not be conclusively determined.

Manufacturer Narrative

One quadripolar, therapy ablation catheter was received for evaluation.The catheter shaft was found to be bent and cracked proximal to the distal tip.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the bent and cracked catheter shaft remains unknown.

• Brand Name: THERAPY¿ ABLATION CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): ST. JUDE MEDICAL; 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ST. JUDE MEDICAL; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15361932
• MDR Text Key: 304716251
• Report Number: 2030404-2022-00057
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P040042
• 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,Followup
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IBI-83459
• Device Lot Number: 8303497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2022
• 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