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

Device Problems Material Frayed (1262); Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2020

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

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 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.

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
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL; 2375 morse ave; irvine CA 92614
• MDR Report Key: 10890044
• MDR Text Key: 217969609
• Report Number: 2030404-2020-00097
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05414734309929
• UDI-Public: 05414734309929
• Combination Product (y/n): N
• PMA/PMN Number: K101623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 11/24/2020
• Supplement Dates Manufacturer Received: 12/09/2020
• Supplement Dates FDA Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1