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 Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); Embolism/Embolus (4438); Foreign Body Embolism (4439)

Event Date 08/14/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

During the procedure, the tip of the catheter detached and remained in the patient.The catheter was introduced into the artery through an 8f short sheath to reach the left ventricle via retrograde approach.Resistance was noted and the catheter could not be advanced any further.Upon withdrawal, resistance was noted again.By pulling on the catheter, the tip of the catheter tore and detached in the patients artery.The catheter was surgically removed and the patient is in stable condition.

Manufacturer Narrative

One bi-directional, curve d-f, sensor enabled, advisor hd grid mapping catheter was received for evaluation.The catheter was returned with the distal tip paddle fractured and detached from the shaft.The spline within the paddle was fractured.It should be noted that an 8f introducer was used.The product instructions for use (ifu) warns that a minimum 8.5f should be used.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the fractured paddle and insertion and withdrawal issue is consistent with damage during use.

Manufacturer Narrative

Corrected information: health effect - clinical code.

• 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: 10436680
• MDR Text Key: 203843751
• Report Number: 3005334138-2020-00376
• 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,Followup
• Report Date: 04/08/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: D-AVHD-DF16
• Device Catalogue Number: D-AVHD-DF16
• Device Lot Number: 7432007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/14/2020
• Initial Date FDA Received: 08/21/2020
• Supplement Dates Manufacturer Received: 03/26/2021; 04/08/2021
• Supplement Dates FDA Received: 03/27/2021; 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1