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

Model Number	IBI-81144
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One inquiry steerable diagnostic catheter was received for evaluation.The device was returned due to a display issue.Dissection revealed conductor wire 12 had been fractured proximal to the weld joint, consistent with the open circuit detected and the reported signal issue.Electrode 11 met specifications of acceptable resistance values with no open or short circuits detected.However, electrode ring 11 was noted to be ¿pressed¿ resulting in an oval shape, and the adhesive bond broken creating a gap between the ring and the catheter shaft.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the fractured conductor wire and misshaped electrode ring is consistent with damage during use.
Event or Problem Description
This report is to advise of an event observed during analysis confirming a displaced electrode.

• Brand Name: INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• MDR Report Key: 8277702
• Report Number: 2030404-2019-00004
• Device Sequence Number: 13876110
• Product Code: DRF
• UDI-Device Identifier: 05414734303309
• UDI-Public: 05414734303309
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/25/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: IBI-81144
• Device Catalogue Number: IBI-81144
• Device Lot Number: 6363054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 01/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1