MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. 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); Activation, Positioning or Separation Problem (2906)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

At the end of the procedure, the catheter was removed from the patient and exposed internal wiring was noted.To check the isolation of the lower right pulmonary vein at the end of the procedure, several rotational movements were made in a clockwise direction in sequence with the circular double loop catheter.After the maneuvers, a deflection issue was noted and when the catheter was removed from the patient, it was verified that the external insulation of the catheter was torn and pulled apart.The procedure was already completed when the issue was noted and there were no adverse consequences to the patient.

Manufacturer Narrative

One image was submitted to product performance engineering.The image appears to show a tear in the catheter shaft material.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported shaft tear could not be conclusively determined.

Manufacturer Narrative

One duodecapolar, double loop, inquiry afocusii diagnostic catheter was received for evaluation.Visual inspection revealed a bend in the catheter shaft 2.3¿ proximal to the sprial loop/shaft transition.A tear was visible in the catheter shaft 2.3¿ proximal to the shaft transition.The catheter deflected when actuating the steering mechanism; however, the catheter did not deflect in the correct shape due to bend in the shaft.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the fractured activation wire is consistent with damage during use.

• 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, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10563902
• MDR Text Key: 208138635
• Report Number: 2030404-2020-00075
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05414734309929
• UDI-Public: 05414734309929
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K101623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2022

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: 07/31/2022
• Device Model Number: IBI-87008
• Device Catalogue Number: IBI-87008
• Device Lot Number: 7131770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/16/2020
• Initial Date FDA Received: 09/21/2020
• Supplement Dates Manufacturer Received: 11/16/2020; 04/22/2022
• Supplement Dates FDA Received: 11/19/2020; 04/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1