MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. INQUIRY¿ FIXED CURVE DIAGNOSTIC CATHETER; ELECTRODE RECORDING CATHETER

Model Number IBI-80244

Device Problems Communication or Transmission Problem (2896); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2017

Event Type  malfunction  

Manufacturer Narrative

The device was returned due to signal loss.Electrodes 2-4 read as an open circuit.Dissection revealed conductor wire 2-3 had been fractured proximal to the weld joint, consistent with the open circuit detected and the reported signal loss issue.Electrode 4 was distally displaced consistent with the electrode ring getting caught on the introducer sheath during the procedure and the open circuit detected.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the fractured conductor wire is consistent with damage during use and the displaced electrode is consistent with the electrode ring getting caught on the introducer sheath.

Event Description

This report is to advise of an event of a dislodged electrode observed during analysis confirming the reported signal loss.

• Brand Name: INQUIRY¿ FIXED CURVE DIAGNOSTIC CATHETER
• Type of Device: ELECTRODE RECORDING CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7510541
• MDR Text Key: 108162828
• Report Number: 2030404-2018-00037
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K946333
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: IBI-80244
• Device Lot Number: 5893361
• Other Device ID Number: 05414734301053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2017
• 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