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

Model Number	A701125
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During a pulmonary vein isolation procedure for paroxysmal atrial fibrillation, a delay occurred.The connection between the catheter and the ampere generator was disconnected when rf delivery was being performed.An error message was displayed on the remote stating the connection to the catheter was disconnected.After a few seconds, the connection was re-established and rf delivery was able to be performed; however, the same issue occurred again after a few times.The connecting cable was exchanged with no resolution.The catheter was replaced and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
One quadripolar, bi-directional, curve d-f, flexibility ablation catheter was received for evaluation.Electrodes 1-4 and the thermocouple 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 connection issue remains unknown.

• Brand Name: FLEXABILITY ABLATION CATHETER, BI-D, CURVE D-F
• Common Device Name: 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
• MDR Report Key: 11262322
• Report Number: 3008452825-2021-00067
• Device Sequence Number: 3786021
• Product Code: OAD
• UDI-Device Identifier: 05415067011114
• UDI-Public: 05415067011114
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: A701125
• Device Catalogue Number: A701125
• Device Lot Number: 6828960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 03/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 62