MAUDE Adverse Event Report: ST. JUDE MEDICAL FLEXABILITY¿ABLATION CATHETER, UNI-D, CURVE D; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number A701157

Device Problems Signal Artifact/Noise (1036); High impedance (1291)

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

Event Date 09/04/2022

Event Type  malfunction  

Event Description

Related manufacturing ref: 3008452825-2022-00596.During a premature ventricular contraction procedure (pvc), two ablation catheters showed abnormal impedance and signal interference which caused a delay.While using the tacticath¿ contact force ablation catheter, sensor enabled to discharge the left ventricular outflow tract for 30 seconds, impedance increased from 105 to over 150, accompanied by signal interference and the radiofrequency instrument automatically cut off the discharge.A flexability¿ablation catheter, uni-d was then used which started normally, however, the same issue occurred approximately 15 minutes later.The catheter was replaced again and the procedure was completed with no consequences to the patient.

Manufacturer Narrative

One quadripolar, uni-directional, curve d, flexability ablation catheter was received for evaluation.Electrode 1 met specifications for acceptable resistance values with no open or short circuits detected.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported impedance issue and subsequent delay remains unknown.

• Brand Name: FLEXABILITY¿ABLATION CATHETER, UNI-D, CURVE D
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15402024
• MDR Text Key: 305697179
• Report Number: 3008452825-2022-00597
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 05415067011497
• UDI-Public: 05415067011497
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P110016
• 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: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A701157
• Device Catalogue Number: A701157
• Device Lot Number: 8296943
• 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: 11/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2022
• 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
• Treatment: TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SE