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

Model Number D128211

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/17/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because 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).

Event Description

It was reported that an unknown male patient underwent an atrial fibrillation persistent ablation procedure with a pentaray nav high-density mapping eco catheter.The patient suffered cardiac tamponade requiring surgical intervention and prolonged hospitalization.It was reported that tamponade occurred at the transition of left atrial appandage (laa) to the atrium.The physician thinks it was caused by the pentaray.The blood pressure decreased immediately, and the tamponade was confirmed with ultrasound.Eventually the patient went into open heart surgery.Due to the reported event, the procedure could not be successfully completed.It is unknown if fragments were generated.The patient underwent surgery and further consequences are not known at the time of reporting.Other medical intervention was required as the patient had to undergo open heart surgery.Additional information was received on (b)(6) 2021.It was reported that the event occurred on (b)(6) 2021.The adverse event was discovered during use of biosense webster inc.(bwi) product, while mapping with the pentaray catheter of the left atrium.This is when it was discovered that the blood pressure was decreasing a lot.Ablation catheter was inside the patient¿s body, but no ablation was performed.In the physician¿s opinion, the pentaray caused the tamponade at the inferior transition of the appendage to the atrium.The medical intervention was puncture to release the blood which was not sufficient.Therefore, patient had to undergo open heart surgery.The patient outcome of the adverse event is not known yet.The patient required extended hospitalization because of the tamponade as he had to undergo open heart surgery.No ablation was performed prior to noting the tamponade.The tamponade was discovered just after the transseptal phase when the mapping phase was started.A transseptal puncture was performed with a non-bwi (abbott) brk needle, then mapping phase started and immediately it was realized the blood pressure was decreasing.After that, the procedure was cancelled.An irrigated catheter was set up to be used in the event with the following flow setting set at: high flow: 17ml/min, however no ablation was performed and low flow: 2ml/min.Correct catheter settings were selected on the generator, but no ablation was performed.Force visualization features were graph, dashboard, and vector.No error messages were observed on the biosense webster equipment during the procedure.The patient was under local anesthesia for 5 hours approximately.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

Additional information was received on (b)(6) 2022.The team thought that the tamponade happened during the transseptal puncture.Only hours later, the physician mentioned that he thought it was due to the pentaray.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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12990260
• MDR Text Key: 286255824
• Report Number: 2029046-2021-02177
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2022
• 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: NON-BWI BRK NEEDLE (ABBOTT).; SMARTABLATE GENERATOR SPARE-WW.; THMCL SMTCH SF BID, TC, D-F.; UNK_CARTO 3.
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Male