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

Model Number	IBI-81174
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	01/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One decapolar, inquiry steerable diagnostic catheter was received for evaluation.The device was returned due to a display issue.Electrode 4 read as an open circuit.A biological foreign material was noted covering electrode 4, interfering with the conductivity of the electrode and consistent with the open circuit detected and the reported display issue.Electrodes 1-3 and 5-10 met specifications of acceptable resistance values.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the electrical issue is due to the biological foreign material covering the electrode.
Event or Problem Description
This report is to advise of an event observed during analysis, confirming tissue on the returned device.

• Brand Name: INQUIRY STEERABLE DIAGNOSTIC CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 9880390
• Report Number: 3008452825-2020-00164
• Device Sequence Number: 3183418
• Product Code: DRF
• UDI-Device Identifier: 05414734303361
• UDI-Public: 05414734303361
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K961924
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: IBI-81174
• Device Catalogue Number: IBI-81174
• Device Lot Number: 7211538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 03/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other