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

Model Number IBI-87002

Device Problem Component Misassembled (4004)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Related manufacturer reference number: 2030404-2020-00060.During device preparation, upon opening the package, a 10-electrode catheter was packaged instead of 14-electrode.Another package was opened, but the same issue was observed.There were no adverse consequences to the patient.Another catheter was used for the procedure.

Manufacturer Narrative

One decapolar, inquiry steerable diagnostic catheter was received for evaluation.The returned catheter was a decapolar, inquiry steerable diagnostic catheter, however, batch number 7397307 is for a 14-pole, inquiry steerable diagnostic catheter.No other visual anomalies were noted.A decapolar catheter was received with a label for a 14-pole catheter, confirming the incorrect catheter was packaged in the box.

• 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: 10455542
• MDR Text Key: 205284311
• Report Number: 2030404-2020-00059
• Device Sequence Number: 1
• Product Code: DRF
• 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,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

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-87002
• Device Lot Number: 7397307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• 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: 10/19/2020
• Supplement Dates FDA Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: FA-Q320-EP-1
• Patient Sequence Number: 1
• Treatment: INQUIRY STEERABLE DIAGNOSTIC CATHETER