MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number D128211

Device Problems Display or Visual Feedback Problem (1184); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 09/28/2022

Event Type  Injury  

Manufacturer Narrative

(b)(6).The biosense webster, inc.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.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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a pentaray nav high-density mapping eco catheter and suffered cardiac tamponade requiring pericardiocentesis and prolonged hospitalization.In a polarx procedure, using a pentaray nav high-density mapping eco catheter as combination, a pericardial effusion was noted and confirmed by intracardiac echo after completion of the cryo ablation procedure.Drainage was performed.A certain amount of blood was drained, and the patient is followed up on in the icu.The physician commented that it is unknown if something happened when polarx was moved greatly inside the cardiac cavity, but the relationship of the event with the product is unknown.There were no abnormalities observed prior to use or during use of the product.This procedure was conducted using polarx.This adverse event was discovered after use of biosense webster products.The physician¿s opinion on the cause of this adverse event is that it was procedure related.Extended hospitalization was required because the patient had to be admitted to the icu.Prior to noting the pericardial effusion, ablation was performed by polarx.There was no evidence of steam pop.Error message was observed as was noted below.Mapping system was a carto3.Rf generator was a smartablate.Vizigo sheath was used.Rf needle was used for septal puncture.Relationship with the product is unknown.Additionally, it was reported that they were unable to display/map due to out of mapping range error despite being in the cardiac cavity.This occurred at insertion into the cardiac cavity.Re-connection was performed, and the cable was changed, but the issue continued.The issue was resolved by changing the pentaray nav sh to another one.The procedure was completed.This complaint will be conservatively reported under the pentaray as they stated that it was a combination procedure, the relationship with the device is unknown, and they had to exchange the pentaray due to the visualization issue.Therefore, it is difficult to exclude bwi devices.Further information has been requested to clarify if the thermocool catheter was used and in what capacity.Should additional information become available this complaint will be reassessed accordingly.

Manufacturer Narrative

The device evaluation was completed on 16-nov-2022.It was reported that a patient underwent a cardiac ablation procedure with a pentaray nav high-density mapping eco catheter and suffered cardiac tamponade requiring pericardiocentesis and prolonged hospitalization.In a polarx procedure, using a pentaray nav high-density mapping eco catheter as combination, a pericardial effusion was noted and confirmed by intracardiac echo after completion of the cryo ablation procedure.Drainage was performed.A certain amount of blood was drained, and the patient is followed up on in the icu.The physician commented that it is unknown if something happened when polarx was moved greatly inside the cardiac cavity, but the relationship of the event with the product is unknown.There were no abnormalities observed prior to use or during use of the product.Device evaluation details: the product was returned to biosense webster (bwi) for evaluation.A visual inspection and an evaluation of all features of the device were performed following bwi procedures.Visual analysis revealed that no damage or anomalies were found on the device.Per the event, functional tests were performed.The magnetic and electrical features were tested, 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 lot: 30784617l and no internal actions related to the complaint were found during the review.No malfunction was observed during the product analysis.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.The instruction 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.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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: PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
• 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: 15678433
• MDR Text Key: 302471162
• Report Number: 2029046-2022-02655
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30784617L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2022
• 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: PENTARAY NAV ECO 7FR, D, 2-6-2.; THMCL SMTCH SF BID, TC, D-F.; UNK BRAND RF NEEDLE.; UNK_CARTO 3.; UNK_CARTO VIZIGO SHEATH.; UNK_SMARTABLATE GENERATOR.
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention