MAUDE Adverse Event Report: ST. JUDE MEDICAL INQUIRY AFOCUSII (4 F DOUBLE LOOP) CATHETER 20 ELECTRODE, 7F; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	IBI-87008
Medical Device Problem Codes	Material Frayed (1262); Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
During the procedure, after the catheter was used in the left atrium and when attempting to perform mapping in the right atrium, the catheter suddenly stopped deflecting.The catheter was not stuck in the valve.The catheter was attempted to be removed from the patient; however, it could not be removed from the 10f sl0 introducer.It could be finally removed after pulling back and forward with force.When the catheter was checked, a part of the blue coating was peeled off and the wires were found to be exposed.The catheter could be deflected after being removed from the patient.The catheter was replaced and the procedure was completed with no adverse consequences to the patient.
Event or Problem Description
During the procedure, after the catheter was used in the left atrium and when attempting to perform mapping in the right atrium, the catheter suddenly stopped deflecting.The catheter was not stuck in the valve.The catheter was attempted to be removed from the patient; however, it could not be removed from the 10f sl0 introducer.It could be finally removed after pulling back and forward with force.When the catheter was checked, a part of the blue coating was peeled off and the wires were found to be exposed.The catheter could be deflected after being removed from the patient.The introducer was aspirated before the replacement catheter was inserted to check if there was any fragment left and it was confirmed that no fragment was left in the introducer and the patient under fluoroscopy.The catheter was replaced and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
One duodecapolar, double loop, inquiry afocusii diagnostic catheter was received for evaluation.The reported damage to the catheter shaft and deflection issue was confirmed, however the removal difficulty could not be confirmed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the catheter damage and deflection issue are consistent with damage during use.The cause of the withdrawal difficulty remains unknown.

• Brand Name: INQUIRY AFOCUSII (4 F DOUBLE LOOP) CATHETER 20 ELECTRODE, 7F
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL; 2375 morse ave; irvine CA 92614
• MDR Report Key: 10890044
• Report Number: 2030404-2020-00097
• Device Sequence Number: 2895083
• Product Code: DRF
• UDI-Device Identifier: 05414734309929
• UDI-Public: 05414734309929
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101623
• 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,Followup
• Report Date (Section B): 12/18/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: IBI-87008
• Device Catalogue Number: IBI-87008
• Device Lot Number: 6755745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/13/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1