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 Entrapment of Device (1212)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 03/18/2021

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 could not be conclusively determined.

Event Description

During an atrial tachycardia (at) ablation procedure, after successful ablation of atrial tachycardia and the patient was in a sinus rhythm, the advisor hd grid was advanced for mapping the sinus rhythm to confirm the location of the sinus node.After mapping, the device was attempted to be removed, however there was resistance felt.An x-ray revealed the hd grid was entangled with two other diagnostic catheters near the femoral iliac vein.The devices were attempted to be removed with no success.Vascular surgery was called for consult, and a snare requiring an additional subclavian access was used to successfully used to untangle and removed the devices.The patient is currently in stable condition.

• 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: 11594985
• MDR Text Key: 243126770
• Report Number: 3005334138-2021-00193
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05415067028198
• UDI-Public: 05415067028198
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K172393
• 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: 03/31/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: D-AVHD-DF16
• Device Catalogue Number: D-AVHD-DF16
• Device Lot Number: 7731787
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/18/2021
• Initial Date FDA Received: 03/31/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2020
• 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