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 Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2019

Event Type  malfunction  

Manufacturer Narrative

Upon receipt of the device, a fractured and detached electrode was noted.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

This report is to advise of an event observed upon receipt of the device revealing a fractured and detached electrode.

Manufacturer Narrative

One decapolar, spiral loop, inquiry afocusii diagnostic catheter was received for evaluation.Visual inspection revealed the distal electrode was fractured and detached from the spiral loop.The distal electrode was not returned.In addition, the spiral loop was stretched and flattened.The catheter shaft met specifications for outer diameter, however due to the condition of the returned device, functional testing could not be performed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the fractured and detached tip electrode and the reported insertion difficulty is consistent with not using the tip straightener to straighten the loop during insertion of the catheter into the introducer sheath.Per the ifu, pulling the thumb control straightens the catheter shaft.Always make sure to pull the thumb control downward completely before removing the catheter from the patient.

• 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
• MDR Report Key: 8531027
• MDR Text Key: 142487572
• Report Number: 2030404-2019-00025
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05414734311434
• UDI-Public: 05414734311434
• Combination Product (y/n): N
• PMA/PMN Number: K042775
• 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: 06/18/2019

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: 06/30/2021
• Device Model Number: D087023
• Device Lot Number: 6548546
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/03/2019
• Initial Date FDA Received: 04/19/2019
• Supplement Dates Manufacturer Received: 06/11/2019
• Supplement Dates FDA Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1