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 Fracture (1260); Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2022

Event Type  malfunction  

Event Description

During the procedure, a device fracture occurred.The device was difficult to maneuver near the end of the procedure; the exterior loop was stuck as it was noted to be crooked at the shaft.Upon removal of the catheter, a fracture was noted.An ablation catheter was used instead of the afocus to check veins and the procedure was completed successfully with no adverse patient consequences.

Manufacturer Narrative

One decapolar, inquiry steerable diagnostic catheter was received for evaluation.The reported fracture in the catheter shaft could not be confirmed, however a bend in the shaft was noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the received condition of the device and the information provided, the cause of the bend 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, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13929659
• MDR Text Key: 289074890
• Report Number: 2030404-2022-00025
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05414734309929
• UDI-Public: 05414734309929
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 05/09/2022

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 Model Number: IBI-87008
• Device Catalogue Number: IBI-87008
• Device Lot Number: 8067025
• 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: 03/21/2022
• Initial Date FDA Received: 03/28/2022
• Supplement Dates Manufacturer Received: 05/04/2022
• Supplement Dates FDA Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other