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

Model Number	IBI-81202
Medical Device Problem Codes	Device Damaged by Another Device (2915); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One inquiry steerable diagnostic catheter was received for evaluation.Slight bends were noted throughout the catheter shaft.Electrode bands 3 and 4 were displaced from the catheter shaft, and had moved distal to weld joints 3 and 4.Electrode bands 5 and 6 were misshapen.Electrodes 3 and 4 read as an open circuit during electrical testing.In addition, electrode rings 3 and 4 were distally displaced.The conductor wires for electrodes 3 and 4 had fractured at the weld joints of the electrode rings, consistent with the open circuits detected, the reported signal issue, and the displaced electrode rings.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the fractured conductor wires is consistent with damage during use.The displaced electrodes is consistent with manipulation of the catheter during use with an introducer sheath.
Event or Problem Description
This report is to advise of an event observed during analysis confirming displaced electrodes on the catheter.

• Brand Name: INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• MDR Report Key: 8035137
• Report Number: 2030404-2018-00074
• Device Sequence Number: 11078265
• Product Code: DRF
• UDI-Device Identifier: 05414734303439
• UDI-Public: 05414734303439
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 11/02/2018

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-81202
• Device Catalogue Number: IBI-81202
• Device Lot Number: 6383953
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2018
• Initial Report FDA Received Date: 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1