MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. LASSOSTAR CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Catalog Number D139001

Device Problems Application Program Problem (2880); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Tamponade (2226)

Event Date 12/03/2020

Event Type  Death  

Manufacturer Narrative

Information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.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 ref.# (b)(4).

Event Description

It was reported that a patient underwent cardiac ablation procedure for atrial fibrillation (afib) with an fda approved lassostar catheter and suffered cardiac tamponade requiring surgical intervention and death.There were multiple products used in the case that could have contributed to the event including the initial transseptal sheath (st.Jude fixed curve sl0 sheath), the guidestar sheath, the heliostar balloon ablation catheter and the lassostar catheter.The patient had initial pericardiocentesis with 1.3 liters of blood removed.Patient required cardiac surgery where the perforation was noted near the atrial septum.Patient eventually succumbed due to cerebral hypoxemia and died.The heliostar balloon catheter is not fda approved and thus not mdr reportable.The smarttouch catheter was not used for ablation but for guiding the heliostar through the transseptal, as such, considered concomitant.The guidestar sheath is a distributed device and therefore not mdr reportable for bwi.The lassostar catheter is fda approved, therefore, based on this information available, the adverse events will be conservatively reported under the lassostar catheter.The physician also reported being unable to acquire points with the lassostar catheter.This issue of not being able to map/acquire points is not considered to be mdr reportable since the potential risk that the issue itself could cause or contribute to a serious injury or death is remote.With the carto 3 system, there was a mismatch between the position of the balloon and the map.The mismatch was only on the balloon catheter.When re-mapped, both maps were perfectly aligned.Upon further review, the issue was understood to be a visualization issue and not a map shift.The carto 3 system also had a pacing issue which was described as, pacing was routed to coronary sinus catheter (cs), but for the system the pacing was coming from the heliostar catheter.The issue was resolved by changing position of the ic-out pin from patient interface unit (piu) to the cardiotek stimulator.The visualization and pacing issues are not considered to be mdr reportable since the potential risk that these could cause or contribute to a serious injury or death is remote.

Manufacturer Narrative

On 1/5/2021, biosense webster inc.Received additional information about the event.It has been reported the physician¿s opinion on the cause of the adverse event (cardiac tamponade) is procedure related, probably occurred during transeptal puncture or second access.During the procedure, transseptal access was lost and the physicians tried to access again to the left side without doing another puncture.Adverse event was discovered post use of biosense webster product.One to two days of extended hospitalization stay were required for monitoring the patient¿s condition.The physician reported that a surgical procedure was performed the night after the procedure.The date of death was on (b)(6) 2020.Additionally, more information about the lassostar catheter, heliostar balloon catheter, and guidestar gheath were provided.It was reported there was an error from the nggen showing that a few thermocouples of the heliostar balloon catheter were not working; as such, the heliostar balloon catheter was exchanged.The issue of not being able to acquire points with the lassostar catheter was also resolved by exchanging the lassostar for a new one.These malfunctions could have been cause by the physician deflecting the guidewire sheath while the lassostar catheter and heliostar balloon catheter were inside the guidewire sheath.There was a 40 minute delay.After the catheters were exchanged, the procedure was completed.The irrigation for the heliostar balloon catheter was set to 5-35ml/min.The following items to the concomitant product section d11.Concomitant med products as per additional information, unk_lassostar catheter, unk_heliostar catheter and the ngen pump, eu configuration.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref#: (b)(4).

Manufacturer Narrative

On 2/5/2021, additional information was received indicating the unit giving the error messages about the ngen generator.As such, the device has been added to section d11.Concomitant med.Products.On 2/12/2021, additional information was received indicating the product code for the lassostar catheter is d139001 and the lot # is 30425343l.As such, the following fields have been updated: 1.Field d2.Common device name has been updated from catheter, electrode recording, or probe, electrode recording to lassostar¿ circular mapping catheter.2.Field d4.Catalog has been updated from unk_lassostar catheter to d139001.3.Field d4.Lot has been updated from ¿blank¿ to 30425343l.4.Field d4.Unique identifier( udi) has been updated from ¿blank¿ to 10846835020236.5.Field h4.Pma/ 510(k) has been updated from ¿blank¿ to k193632.Additionally, with the lot number being made available, the d4.Expiration date and h4.Device manufacture date have been populated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

On 4/2/2021, additional information was received indicating that a smarttouch catheter was not used during this procedure.As such, please consider this removed from the d11.Concomitant med.Products field.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: LASSOSTAR CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 11098718
• MDR Text Key: 224515030
• Report Number: 2029046-2020-02019
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• PMA/PMN Number: K193632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/04/2020

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 Expiration Date: 08/19/2021
• Device Catalogue Number: D139001
• Device Lot Number: 30425343L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 01/05/2021; 02/05/2021; 04/02/2021
• Supplement Dates FDA Received: 02/02/2021; 03/03/2021; 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARDIOTEK STIMULATOR; CARTO 3 SYSTEM; NGEN PSU; NGEN PUMP, EU CONFIGURATION; UNK_GUIDESTAR STEERABLE SHEATH; UNK_HELIOSTAR CATHETER; UNK_HELIOSTAR CATHETER; UNK_LASSOSTAR CATHETER; UNK_SMART TOUCH BIDIRECTIONAL; CARDIOTEK STIMULATOR; CARTO 3 SYSTEM; UNK_GUIDESTAR STEERABLE SHEATH; UNK_HELIOSTAR CATHETER; UNK_SMART TOUCH BIDIRECTIONAL
• Patient Outcome(s): Death; Hospitalization; Required Intervention