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

Model Number IBI-81104

Device Problem Component Misassembled (4004)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/05/2020

Event Type  malfunction  

Manufacturer Narrative

The results, method and conclusion codes along with investigation results will be provided in the final report.

Event Description

During a procedure, it was found that the incorrect catheter was in the packaging.The physician did attempt to use the device, but after it was inserted into the patient it was decided to exchange the catheter for another device.The procedure was completed with no adverse consequences to the patient.

Manufacturer Narrative

The device was not returned for analysis; however, it was confirmed that the package was labeled with the incorrect information.From previous investigation it was confirmed that the catheter from the batch number 7397352 were with 10 electrodes, was packaged with the label of the catheter from the batch number 7397307 were with 14 electrodes and vice versa.

• Brand Name: INQUIRY STEERABLE DIAGNOSTIC CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• MDR Report Key: 10455592
• MDR Text Key: 204599560
• Report Number: 2030404-2020-00065
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05414734302975
• UDI-Public: 05414734302975
• Combination Product (y/n): N
• PMA/PMN Number: K961924
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

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: 01/31/2023
• Device Model Number: IBI-81104
• Device Catalogue Number: IBI-81104
• Device Lot Number: 7397352
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: 02/24/2021
• Supplement Dates FDA Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: FA-Q320-EP-1
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 85