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 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: 2030404-2020-00061, 2030404-2020-00063.During preparation, it was noted that the incorrect catheter was in the packaging on three different catheters.A fourth catheter was used to complete the procedure.There were no adverse consequences to the patient.

Manufacturer Narrative

One 14-pole, inquiry steerable diagnostic catheter was received for evaluation.The returned catheter was a 14-pole, inquiry steerable diagnostic catheter, however, batch number 7397352 is for a decapolar, inquiry steerable diagnostic catheter.No other visual anomalies were noted.A 14-pole catheter was received with a label for a decapolar 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: 10455561
• MDR Text Key: 204420402
• Report Number: 2030404-2020-00062
• 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: 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-81104
• Device Catalogue Number: IBI-81104
• Device Lot Number: 7397352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• 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 X2; INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER X2
• Patient Weight: 80