MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC INQUIRY ELECTROPHYSIOLOGY CATHETER, INQUIRY AFOCUS II EB CATHETER, 110 CM LEN; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number D087023

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2020

Event Type  malfunction  

Manufacturer Narrative

One decapolar, spiral loop, inquiry afocusii diagnostic catheter was received for evaluation.One image was also submitted for evaluation.The photograph appeared to show the catheter shaft at the loop torn with the conductor wires exposed.Visual inspection revealed the catheter shaft on the loop was torn, exposing the conductor wires.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause the torn loop and exposed conductor wires is consistent with damage during use.

Event Description

This report is to advise of an event observed during analysis confirming a torn loop, exposing the conductor wires.

• Brand Name: INQUIRY ELECTROPHYSIOLOGY CATHETER, INQUIRY AFOCUS II EB CATHETER, 110 CM LEN
• 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: 10366879
• MDR Text Key: 202993511
• Report Number: 2030404-2020-00054
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05414734311434
• UDI-Public: 05414734311434
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K010471
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/05/2020

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: 07/31/2022
• Device Model Number: D087023
• Device Catalogue Number: D087023
• Device Lot Number: 7121026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/29/2020
• Initial Date FDA Received: 08/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1