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

Model Number D-AVHD-DF16

Device Problems Improper or Incorrect Procedure or Method (2017); Air/Gas in Device (4062)

Patient Problem Air Embolism (1697)

Event Date 06/29/2023

Event Type  Death  

Event Description

During the redo af/aflutter procedure, an air embolism occurred, and the patient expired.The patient was prepped in the procedure room around 7am.The patient's rhythm was atrial fibrillation with rapid ventricular response.During preparation, the staff set up necessary equipment including heparinized saline bags for catheter irrigation.A cool point pump was used with the tacticath se for administering irrigation via a 1000ml irrigation bag, whereas the advisor hd grid was set up to be irrigated directly via a 500ml pressure bag instead of a cool point pump.A flow regulator was not utilized with the pressure bag; the tubing set included a rolling ball regulator which was set in the free flow position for the duration of the procedure.Neither of the two irrigation bags were replaced during the procedure.The introducer used with the advisor hd grid was a non-abbott product (biosense-webster vizigo) and was flushed upon insertion into the patient, but was not irrigated when in use during the procedure.The staff was informed and aware of the setup and items to monitor, and the procedure began at around 7:30am.The right atrium was first mapped with the advisor hd grid mapping catheter, after which transseptal puncture to the left atrium was performed under guidance from a non-abbott intracardiac ultrasound catheter and with a non-abbott transseptal sheath and non-abbott radiofrequency transseptal needle system (baylis versacross).The advisor hd grid was advanced into the left atrium and the physician mapped the chamber in af.Following mapping, the non-abbott sheath was introduced into the left atrium and the tacticath se ablation catheter was introduced through the sheath.Ablation was performed on the posterior wall of the left atrium (la), the roof and floor of the la, and the lateral wall/mitral isthmus.Ablation took approximately 3.5 hours.The catheters were withdrawn to the right atrium where mapping was performed to assess need for further ablation in the right atrium.No ablation was performed in the right atrium.The advisor hd grid and non-abbott sheath were then used to access the la again through the existing transseptal puncture where a remap of the la was performed.At approximately the fourth hour of the procedure (~11:30am), the advisor hd grid was removed from the patient to be exchanged for the tacticath se.Upon device exchange, the physician noted that he saw bubbles when aspirating the non-abbott sheath with a syringe.At this time, the circulating nurse noted that one of the pressurized heparinized saline irrigation bags was empty and that they did not see any fluid going through.The physician noted the bag was connected to the flush line for the advisor hd grid and stated that air was being pushed through the advisor hd grid into the la.The physician used ice and confirmed air in the la just past the aortic root.It was unknown how long the advisor hd was used without irrigation.It was noted that the same pressurized hep-saline bag leading to the advisor hd grid had two spiked tubing sets (one tubing set was connected to the advisor hd grid and the other was connected to an arterial line).Another bag was spiked with the advisor hd outside the body and the arterial line in place.Several minutes later, the patient began to decompensate.The physician, lab staff, and anesthesiologist began to tend to the patient.The physician initiated pacing in the right ventricle via the ablation catheter due to no electrical activity, and a lab staff member began chest compressions around 12:00pm.A code blue was called at around this time and the emergency response team arrived to perform chest compressions and further treatment.During the resuscitative attempts, blood gases were drawn radially and not from the arterial line.Coding of the patient lasted approximately 45 minutes until the patient was pronounced deceased at 12:44pm.The catheters were left in the patient until internal checks were performed and then were immediately removed and taken.Following the event, the physician believed the cause of the air entry was due to improper flow management during the case resulting in early depletion of the irrigation bag and/or was user related due to not recognizing the empty irrigation bag.There were no performance issues with the advisor hd grid or any abbott device.

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.The advisor hd grid instructions for use (ifu) states, "maintain constant irrigation to prevent coagulation on the distal paddle.Inspect irrigation tubing for obstructions, such as kinks and air bubbles.If irrigation is interrupted, remove the catheter from the patient and inspect the catheter".Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17409815
• MDR Text Key: 319897088
• Report Number: 3008452825-2023-00323
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/27/2023

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 Model Number: D-AVHD-DF16
• Device Catalogue Number: D-AVHD-DF16
• Device Lot Number: 8768227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/27/2023
• Initial Date FDA Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 122 KG