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 Signal Artifact/Noise (1036); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2019

Event Type  malfunction  

Event Description

During a pulmonary vein isolation ablation procedure, catheter electrode distortion was noted during the last 20 minutes of the procedure.When the catheter was removed from the patient, damage was noted to the "paddle" of the catheter, exposing the internal wiring of the device.The procedure was already completed with no adverse consequences to the patient.

Manufacturer Narrative

One bi-directional, curve d-f, sensor enabled, advisor hd grid mapping catheter was received for evaluation, along with three photos.The images appear to show physical damage to the paddle proximal to electrode 16 and a distorted image during mapping.Microscopic analysis revealed the pellethane tubing was torn proximal to electrode 16 exposing the nitinol frame.Electrodes 1-16 met specifications for acceptable resistance values with no open or short circuits detected.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported display issue remains unknown.The cause of the torn pellethane tubing 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: 8369519
• MDR Text Key: 137127529
• Report Number: 3005334138-2019-00111
• 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: 07/09/2019

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: 05/31/2020
• Device Model Number: D-AVHD-DF16
• Device Lot Number: 6761868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 02/26/2019
• Supplement Dates Manufacturer Received: 07/08/2019
• Supplement Dates FDA Received: 07/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other