MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OCTARAY, GALAXY, 48P, 3-3-3-3-3, F-CURVE; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number D160906

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/29/2022

Event Type  Injury  

Event Description

It was reported that an unknown patient underwent a atrial fibrillation (afib) ablation procedure with a octaray, galaxy, 48p, 3-3-3-3-3, f-curve.The patient suffered cardiac tamponade requiring a pericardiocentesis.It was reported that during an afib procedure, a cardiac tamponade was noticed.The bwi representative reported that before beginning any ablation the physician had a hard time attempting to go transeptal and spent a lot of time attempting to go transeptal.The physician mapped the right atrium to get a better idea of the anatomy with the octaray catheter, pulled the octaray catheter out of the body, and attempted to go transeptal again for 30 minutes when anesthesia alerted the physician that the patient's blood pressure had dropped.The physician used the soundstar ice catheter to view the ventricle and confirmed a cardiac tamponade.The medical intervention provided was a pericardiocentesis and about 250 ml of blood was removed from the pericardial space.The patient was observed for half an hour, they gave iv fluid to the patient, and the physician was able to go transeptal.The procedure was completed.The patient experienced some chest pain after the procedure, but that the patient was stable.The patient was admitted to the hospital.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.

Manufacturer Narrative

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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 26-dec-2022, bwi received additional information regarding the event.The adverse event was discovered before and during the use of bwi products (octaray, soundstar).Physician¿s opinion on the cause of this adverse event was that patient was dehydrated and physician commented that it made the anatomy shrivel.Iv fluid was given, and the physician was able to proceed with the transseptal.Intervention provided was pericardiocentesis and a continuation of the case.The outcome of the adverse event was recovered.Patient required extended hospitalization because of the adverse event as the patient was admitted after placing pericardiocentesis drains.The bleeding stopped.Patient¿s age at the time of the event was possibly in the 60s.Gender was female possibly weighing 95 pounds.Relevant tests/laboratory data was npo since night before.Other relevant history was unknown.Generator information was a g4c-5214-a.Brk-1 needle was used for transseptal puncture performed.Ablation was not performed prior to noting the pe or ct.There was no evidence of steam pop.The event occurred during the during transseptal phase.Irrigation catheter not used prior to complication occurring.Lot/serial number of products was unknown.For concomitant products section: "unspecified transseptal needle" changed to brk-1 needle.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 25-may-2023, the product investigation was completed as the complaint device was not returned.Since no device has been received for analysis, 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: OCTARAY, GALAXY, 48P, 3-3-3-3-3, F-CURVE
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• 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: 16043112
• MDR Text Key: 306091417
• Report Number: 2029046-2022-03237
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2023

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 Model Number: D160906
• Device Catalogue Number: D160906
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/29/2022
• Initial Date FDA Received: 12/23/2022
• Supplement Dates Manufacturer Received: 12/26/2022; 05/25/2023
• Supplement Dates FDA Received: 01/18/2023; 06/08/2023
• Was Device Evaluated by Manufacturer?: No
• 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: BRK-1 NEEDLE; SMARTABLATE GENERATOR; SOUNDSTAR CATHETER; UNSPECIFIED TRANSSEPTAL NEEDLE
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Sex: Female