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

Model Number IBI-81202

Device Problems Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2018

Event Type  malfunction  

Manufacturer Narrative

One inquiry steerable diagnostic catheter was received for evaluation.Slight bends were noted throughout the catheter shaft.Electrode bands 3 and 4 were displaced from the catheter shaft, and had moved distal to weld joints 3 and 4.Electrode bands 5 and 6 were misshapen.Electrodes 3 and 4 read as an open circuit during electrical testing.In addition, electrode rings 3 and 4 were distally displaced.The conductor wires for electrodes 3 and 4 had fractured at the weld joints of the electrode rings, consistent with the open circuits detected, the reported signal issue, and the displaced electrode rings.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the fractured conductor wires is consistent with damage during use.The displaced electrodes is consistent with manipulation of the catheter during use with an introducer sheath.

Event Description

This report is to advise of an event observed during analysis confirming displaced electrodes on the catheter.

• Brand Name: INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING
• 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8035137
• MDR Text Key: 127889191
• Report Number: 2030404-2018-00074
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05414734303439
• UDI-Public: 05414734303439
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K961924
• 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: 11/02/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: IBI-81202
• Device Catalogue Number: IBI-81202
• Device Lot Number: 6383953
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/20/2018
• Initial Date FDA Received: 11/02/2018
• Date Device Manufactured: 03/28/2018
• 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