MAUDE Adverse Event Report: BIOSENSE WEBSTER INC DECANAV ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number R7F282CT

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Air Embolism (1697); Ischemic Heart Disease (2493)

Event Date 02/10/2023

Event Type  Injury  

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number lot 30977496m and no internal actions related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with an octaray, galaxy, 48p, 3-3-3-3-3, d-curve and a decanav electrophysiology catheter.The patient suffered an air embolism and electrocardiogram st segment elevation.During the procedure, an adverse event occurred.The physician placed a decanav electrophysiology catheter in the cf and reprocessed sterilmed soundstar catheter in the right atrium for transseptal access.They reported they also used a torflex transseptal guiding sheath and a safestep needle as well.The physician was not successful in doing the transseptal with the safestep needle and exchanged it for the baylis rf large-curve transseptal needle (nrg-e-hf-71-c1).The physician's baylis needle-mapped the left atrium with an octaray catheter and the physician pulled back the sheath and had a wire across the transseptal and he was getting ready to send across a second needle when the anesthesia team reported that the patient was hypotensive.The ecg showed st elevation.The physician and staff then performed a tee ultrasound and the physician concluded that air had gotten into the left side of the body and there was an air embolus in the apex of the left ventricle.The patient was stabilized, and all catheters were removed.The medical intervention performed was the patient was placed in reverse trendelenburg and kept under anesthesia and intubated, the team will monitor the patient to check to see if the embolus is re-absorbed in the left ventricle.The physicians are unsure of what device caused the air.They noted that all transseptal devices were normal and followed protocol.The catheters involved in the procedure were the decanav electrophysiology catheter, reprocessed sterilmed soundstar and octaray catheter.Additional information was received on 14-feb-2023.The lot number for the cable was not recognized.The lot number on the sterilmed box for the reprocessed siemens 8 fr soundstar was 218970.No irrigation pump was being used during the procedure.They did not introduce an ablation catheter into the body.The adverse event was discovered during use of biosense webster products.Physician¿s opinion on the cause of this adverse event was that it was procedure related as it was unknown how the air was introduced into the body.Patient condition is stable.Outcome of the adverse event was unknown at this time.Patient required extended hospitalization because of the adverse event as patient was scheduled as outpatient.Patient required to admit as inpatient for intensive care unit (icu) level care.Other relevant history: paroxysmal afib.Additional information was received on 24-feb-2023.The event did not require medical or surgical intervention.Surgery was delayed due to the reported event.The procedure was not successfully completed, it was abandoned before ablating.Action taken when event occurred was that patient was placed in reverse-trendelenburg and continued general anesthesia.The reason for the drop-in blood pressure determined to be caused by the air embolus.The case was abandoned.The soundstar catheter functioned as expected.There was no concern with the soundstar eco 8f diagnostic ultrasound catheter.The adverse event was assessed to be reported under both the octaray, galaxy, 48p, 3-3-3-3-3, d-curve and the decanav electrophysiology catheter.

• Brand Name: DECANAV ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16510724
• MDR Text Key: 310953948
• Report Number: 2029046-2023-00501
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835008807
• UDI-Public: 10846835008807
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080425
• 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: 03/08/2023

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 Expiration Date: 01/04/2024
• Device Model Number: R7F282CT
• Device Catalogue Number: R7F282CT
• Device Lot Number: 30977496M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2023
• Initial Date FDA Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2023
• 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
• Treatment: NON BWI-BAYLIS RF LARGE-CURVE TRANSSEPTAL NEEDLE.; NON BWI-SAFESTEP NEEDLE.; NON BWI-TORFLEX TRANSSEPTAL GUIDING SHEATH.; OCTA,LNG,48P,3-3-3-3-3,D-CURVE.; REPROCESS SDSTR ECO 8F-90 SMS.; UNKNOWN BRAND CABLE.
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Sex: Male