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	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturer ref: (b)(4).During a premature ventricular contractions ablation procedure, a prolonged procedure occurred due to a deflection issue with the catheter, the tip of the introducer being bent, and having to exchange both of the devices.The devices were exchanged 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.Multiple bends were noted in the shaft of the catheter.The catheter deflected when actuating the steering mechanism and the curve dimensions met specifications; however deflected out of plane due to the bends in the shaft of the catheter.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the bends in the shaft and the out of plane deflected curve 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
• 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: 12813605
• Report Number: 3008452825-2021-00538
• Device Sequence Number: 17311669
• Product Code: OAD
• UDI-Device Identifier: 05415067011114
• UDI-Public: 05415067011114
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2022

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: 12/31/2023
• Device Model Number: A701125
• Device Catalogue Number: A701125
• Device Lot Number: 7821211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 01/06/2022
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown