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 Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombus (2101)

Event Date 07/11/2019

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident remains unknown.

Event Description

During a posterior wall isolation procedure, a blood clot was noted on the tip of the device.At the beginning of the procedure, the device was flushed with 20,000u heparin in 1000ml saline.The device was placed into the left atrium through the sheath with heparinized saline and the pressure bag open to flush.The outside of the sheath was also flushed with heparinized saline.When the device was placed through the sheath, a small clot was noted on the tip of the coupler.The device was removed, flushing of the sheath was stopped and aspiration of 30cc of blood was performed.The flushing process was repeated, and the device was wiped with saline and inspected before being reintroduced into the patient.The procedure was completed with no adverse patient consequences.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8830793
• MDR Text Key: 152328240
• Report Number: 3005334138-2019-00414
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05415067028198
• UDI-Public: 05415067028198
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: D-AVHD-DF16
• Device Lot Number: 6818877
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/11/2019
• Initial Date FDA Received: 07/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2019
• 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): Required Intervention