MAUDE Adverse Event Report: ST. JUDE MEDICAL ADVISOR HD GRID MAPPING CATHETER, SENSOR ENABLED; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number D-AVHD-DF16

Device Problems Entrapment of Device (1212); Material Frayed (1262)

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

Event Date 11/17/2020

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 an atrial fibrillation ablation procedure, while mapping was being performed in the right atrium, a non-abbott catheter became entangled with the abbott mapping catheter.There was difficulty with removing both catheters from the patient, which caused the internal wires of the abbott catheter to be exposed.Both catheters were able to be removed with no intervention or adverse consequence to the patient.Since the mapping had already been performed, the catheter was not replaced.The procedure was completed with no further issues.After the procedure, it was confirmed that no piece of any device was left inside the patient via echocardiogram.

Manufacturer Narrative

One bi-directional, curve d-f, sensor enabled, advisor hd grid mapping catheter was received for evaluation.The distal coupler and paddle electrodes were displaced and the pellethane tubing was corrugated and torn.In addition, the conductor wires were fractured.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the fractured wires, torn pellethane tubing and displaced coupler and electrodes is consistent with damage during use.

• Brand Name: ADVISOR HD GRID MAPPING CATHETER, SENSOR ENABLED
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10967336
• MDR Text Key: 220205781
• Report Number: 3005334138-2020-00601
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05415067028198
• UDI-Public: 05415067028198
• Combination Product (y/n): N
• PMA/PMN Number: K172393
• 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: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: D-AVHD-DF16
• Device Catalogue Number: D-AVHD-DF16
• Device Lot Number: 7524057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1