MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETERS; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number BNI35BDH

Device Problems Device Contamination with Body Fluid (2317); High Readings (2459); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 06/15/2022

Event Type  Injury  

Manufacturer Narrative

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.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2022-01602 for product code bni35bdh (thermocool® sf nav bi-directional catheter) (2) mfr # 2029046-2022-01603 for product code bni35bdh (thermocool® sf nav bi-directional catheter).

Event Description

It was reported that a male patient underwent a premature ventricular contraction (pvc) ablation procedure with two thermocool® sf nav bi-directional catheters (2) and suffered cardiac tamponade requiring pericardiocentesis.During the pvc procedure, the catheter was advanced to the target site right ventricle (rv), impedance was shown as about 200 ohm.They exchanged to a new cable but there is no change on the impedance, and then, the catheter was replaced with a new catheter of the same type but the value did not change.Therefore, when the catheter was moved to another position, the value was around 130 ~ 180 ohm.First ablation was conducted as 30w/5sec and impedance was 53 ohm down from the starting of 234 ohm.The second ablation was conducted at 30w/5sec and impedance was 52 down from the starting of 204 ohm.After switching to lifeline ablaze, decreased blood pressure was confirmed.Then, setting was set at 50 w with ablaze (w was changed at 1 ~ 40 w) and ablation was started at 135 ohm (max 152 ohm), 27 seconds ablation was performed.Cardiac tamponade was confirmed by echo, and drainage was started.Echo was confirmed again, blood pressure returned to normal limits, and the patient returned to the room.The physician's opinion on the relationship between the event and the product is that there may have been an impedance abnormality.The adverse event occurred on (b)(6) 2022.It was discovered post use of biosense webster catheters.The two defective bwi catheters were removed due to product malfunction, the ablation procedure was continued with another company's catheter and adverse event was confirmed when the ablation was performed with the other company's ablation catheter.The physician¿s opinion on the cause of this adverse event is that it was due to the procedure.The patient outcome of the adverse event is improved.Prior to noting the pericardial effusion, ablation was performed.There was no evidence of a steam pop.The event occurred during the ablation phase.The ablation never continued beyond the cut-off value.Generator parameters was power control mode.The complaint products will be returned for analysis.No error was message observed during the procedure.No issue related to the temperature and flow on catheter was observed.A smartablate generator with product code m4900207 and serial number was (b)(4) was used.The catheter will be returned for analysis.No neurological symptoms were observed on the patient.The duration of ablation used was less than 60 seconds.This complaint will be coded with char.Follow up has been done to clarify the response received that no char /coagulum/thrombus/clot was confirmed as there is discrepancy with the photograph provided.Should additional information become available this complaint will be reassessed.Since the event (cardiac tamponade) is life threatening and required intervention and prolonged hospitalization to prevent permanent impairment of a body function or permanent damage to a body structure, is to be considered serious and mdr-reportable.The high impedance was assessed as not mdr reportable.Since the user-defined cut-off was not exceeded the potential that it could cause or contribute to a death, serious injury, or other significant adverse event, is remote.Char was assessed as not mdr reportable.Char is a physical phenomenon of radiofrequency (rf) energy delivery and can be the normal result of the ablation process.The presence of char on the electrodes does not represent a serious injury in itself, nor is it necessarily the result of device malfunction.

Manufacturer Narrative

Additional information was received on 01-aug-2022.The first ablation catheter¿s lot number was 30703467l, and the second was 30695591l.Both catheters had high impedance issue.No issue occurred on the smartablate generator.Transseptal puncture was conducted with rf needle.Based on this additional information, the concomitant product section was updated.Correct catheter settings were selected on the generator.No issue observed with pump.The pump was switching from ¿low¿ to ¿high¿ flow during ablation.No error message observed during the procedure.Df, realtime graph, vector force visualization features were used.Additional information was received on 8-aug-2022.It was reported that there was no char /coagulum/thrombus/clot was confirmed.The patient was anticoagulated, but act practice was unknown.The patient has not exhibited any neurological symptoms since the procedure was completed.Heparinized normal saline was used as the irrigation fluid.Visitag module was used with the respiration filter.The device evaluation was completed on 10-aug-2022.It was reported that a male patient underwent a premature ventricular contraction (pvc) ablation procedure with two thermocool® sf nav bi-directional catheters (2) and suffered cardiac tamponade requiring pericardiocentesis.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 on the device.Per the event, several tests were performed.The magnetic, electrical, temperature and force 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 device history record review was performed for the finished device 30695591l number, 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.Biosense webster manufacturer's reference number pc-001143942 has two reports: (1) mfr # 2029046-2022-01602 for product code bni35bdh (thermocool® sf nav bi-directional catheter) (2) mfr # for product code bni35bdh (thermocool® sf nav bi-directional catheter) on 01-aug-2022, additional information was received and the code of "char" (imdrf code of device contamination with body fluid (a180103)) has been removed since it was noted that the picture that was initially presented was from another issue not related to this complaint.Therefore, h6.Medical device problem code reflects the two codes that remain applicable.

• Brand Name: THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETERS
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 15009315
• MDR Text Key: 295856858
• Report Number: 2029046-2022-01603
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835003154
• UDI-Public: 10846835003154
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031/S025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BNI35BDH
• Device Catalogue Number: BNI35BDH
• Device Lot Number: 30695591L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2021
• 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: SMARTABLATE GEN. KIT (JAPAN); SMARTABLATE GEN. KIT (JAPAN); THERMOCOOL SF CARTOXP,B-D,TC; UNK BRAND CABLE; UNK BRAND CABLE; UNK BRAND RADIOFREQUENCY (RF) NEEDLE; UNK JAPAN LIFELINE ABLAZE CATHETER
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Male