MAUDE Adverse Event Report: ST. JUDE MEDICAL INQUIRY¿ ELECTROPHYSIOLOGY CATHETERS, DECAPOLAR, 6F; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number IBI-81102

Device Problems Signal Artifact/Noise (1036); Fracture (1260)

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

Event Date 01/30/2023

Event Type  malfunction  

Manufacturer Narrative

One decapolar, inquiry steerable diagnostic catheter was received for evaluation.Dissection revealed conductor wire 9 had been fractured proximal to the weld joint, consistent with the open circuit detected and the reported noise.Electrode 10 met specifications of acceptable resistance values.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the fractured conductor wire remains unknown.

Event Description

This report is to advice of a fracture noted during analysis.

Event Description

Additional information received from the rep stated this issue was not visible in the lab and likely occurred during shipping.Therefore, this is not a reportable event.

• Brand Name: INQUIRY¿ ELECTROPHYSIOLOGY CATHETERS, DECAPOLAR, 6F
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 16553239
• MDR Text Key: 311405079
• Report Number: 3008452825-2023-00095
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05414734302968
• UDI-Public: 05414734302968
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K961924
• 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: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IBI-81102
• Device Catalogue Number: IBI-81102
• Device Lot Number: 8646844
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2022
• 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