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

Model Number R7D282CT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Cardiac Tamponade (2226)

Event Date 07/13/2022

Event Type  Injury  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a 65-year-old female patient (overweight) underwent an idiopathic ventricular tachycardia (idvt) ablation procedure decanav electrophysiology catheter.The patient had a cardiac tamponade requiring surgical drainage and prolonged hospitalization.During an idvt case on wednesday, after going up with ultrasound and taking a number of contours, a baseline effusion was observed.They continued by placing the cs (coronary sinus) catheter to star mapping and noticed that the effusion had gotten larger shortly into the case, and the physician began to reverse with protamine.They monitored the effusion to see if it would continue to grow; the effusion did not continue to grow and pull the catheter and continued to monitor with ultrasound.The first catheter in was the ultrasound catheter, and the last catheter out was also the ultrasound catheter.Transthoracic echo was also used to monitor.As soon as the effusion was noticed, they stopped the case and began reverting to using protamine.The patient is in stable condition.The deca nav catheter is speculated to have caused a micro tear when it was placed, but under monitoring, there was no proof that a tear was made.The physician does not suspect that anything is wrong with the product and believes it was more weakness of the vascular tissue of the patient.Using the color doppler from ultrasound which shows the flow of fluid did not show any abnormality but did not show anything.Everything appeared to be normal.The physician believes this was a result of patient condition.Intervention consisted of protamine administration and monitoring on ultrasound.I was informed today (b)(6) 2022 by the physician that after the patient was moved to icu, effusion was observed to have grown.Effusion was then surgically drained.Patient is fully recovered.The patient required extended hospitalization because of the adverse event.The patient was kept 5 nights for observation and discharged (b)(6) 2022.The generator used in the case was a smartablate generator.Transeptal was performed with the baylis nrg.No ablation was performed.The event occurred during mapping phase.No irrigated or contact force catheters put in the body.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15181102
• MDR Text Key: 297412410
• Report Number: 2029046-2022-01813
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835008791
• UDI-Public: 10846835008791
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/07/2022

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: R7D282CT
• Device Catalogue Number: R7D282CT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/13/2022
• Initial Date FDA Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: BAYLIS NRG TRANSSEPTAL NEEDLE; SMARTABLATE GENERATOR
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female