MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETE; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number NI75TCJH

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 12/20/2021

Event Type  Injury  

Event Description

It was reported that an (b)(6) male patient underwent an atrial fibrillation (afib) ablation procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter.The patient suffered cardiac tamponade requiring pericardiocentesis.It was reported that during an afib case, a pericardial effusion was noticed as the patient's blood pressure dropped.The pericardial effusion was confirmed by ice.The medical intervention provided was a pericardiocentesis and 460ml of fluid was removed.The patient was reported to be in stable condition.The physician stated they had a small steam pop ablating the floor of the left atrium.This adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse is that it was caused by the procedure ¿ steam pop at floor of left atrium (la).The medical intervention provided was pericardiocentesis; ffp, and k-centra given.The patient outcome of the adverse event is fully recovered (no residual effects).Generator information: smartablate, (b)(4).A transseptal puncture was performed.Needle product details: baylis standard c0; ref # (b)(4).Prior to noting the pe or ct ablation was performed.The event occurred during the ablation phase.An irrigated catheter was used in the event, the flow setting was 30 ml/min.Correct catheter settings were selected on the generator.The pump was switching from ¿low¿ to ¿high¿ flow during ablation.No error messages were observed on biosense webster equipment during the procedure.Steam pop is not mdr-reportable.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

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 (b)(6) 2022, the bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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 13-feb-2022, the product investigation was completed.It was reported that an 85-year-old male patient underwent an atrial fibrillation (afib) ablation procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter.The patient suffered cardiac tamponade requiring pericardiocentesis.It was reported that during an afib case, a pericardial effusion was noticed as the patient's blood pressure dropped.The pericardial effusion was confirmed by ice.The medical intervention provided was a pericardiocentesis and 460ml of fluid was removed.The patient was reported to be in stable condition.The physician stated they had a small steam pop ablating the floor of the left atrium.Device evaluation details: visual analysis of the returned product revealed that no damage or anomalies were observed on the navistar device.Per the event, several tests were performed.The magnetic, temperature and electrical tests were performed and no issues were observed.In addition, the product was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device 30466608m number, and no internal action related to the complaint was found during the review.No malfunction was observed during the product analysis.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.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: NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETE
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13219846
• MDR Text Key: 287561614
• Report Number: 2029046-2022-00073
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835000573
• UDI-Public: 10846835000573
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2023
• Device Model Number: NI75TCJH
• Device Catalogue Number: NI75TCJH
• Device Lot Number: 30466608M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2020
• 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 STANDARD C0 NEEDLE.; SMARTABLATE GENERATOR.
• Patient Outcome(s): Required Intervention; Life Threatening