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 Fracture (1260); Activation, Positioning or Separation Problem (2906)

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

Event Date 08/17/2022

Event Type  malfunction  

Event Description

During the ventricular tachycardia procedure, the catheter broke when the 4 distal electrodes remained in the curved position (at 180°) in the artery, while being introduced into a non-abbott sheath.When the catheter was withdrawn, internal wiring was exposed.There were no adverse patient consequences.

Manufacturer Narrative

One quadripolar, uni-directional, curve d, flexability ablation catheter was received for evaluation.The catheter shaft was fractured and twisted proximal to electrode ring 4.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the damage to the shaft 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: 15275332
• MDR Text Key: 305192912
• Report Number: 3008452825-2022-00568
• 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: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• 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: 09/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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