MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D132705

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/17/2021

Event Type  Injury  

Event Description

It was reported that an unknown patient underwent an atrial tachycardia (at) procedure with a thermocool® smart touch¿ electrophysiology catheter and the patient suffered cardiac tamponade.Atrial tachycardia case was mapped with a decanav catheter and ablation performed with an unspecified thermocool® smart touch¿ electrophysiology catheter at 25w.Irrigation and force were normal throughout the case.No ablation index at site.No events during the case.Alerted the next day that patient had tamponade post case 1hr later.Patient did not experience a post-op device malfunction.

Manufacturer Narrative

Device investigation details: since no device has been received for analysis, 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).

Manufacturer Narrative

On 21-dec-2021, biosense webster inc.Received additional information about the patient and event.It was reported that the patient¿s outcome from the adverse event is fully recovered, however, no information provided on the intervention provided.The carto 3 system had no issue or errors; the system functioned as per normal for case.This adverse event was discovered post use of biosense webster products.Physician¿s opinion on the cause of this adverse event is that it was procedure and operator related.No transseptal puncture was performed.Prior to noting the cardiac tamponade ablation was already performed.No evidence of steam pop.The correct catheter settings were selected on the generator and the pump was switching from low to high flow during ablation.It is unknown if the patient required extended hospitalization because of the adverse event.Unknown generator and unknown pump were added to field d10.Concomitant med product as per the additional information received.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

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.(b)(4).Correction: on 15-mar-2022, it was noticed that an incorrect date (typo) was reported under the h10.Additional manufacturer narrative of the 3500a supplemental medwatch report # 2.The incorrect date was "24-feb-2022" the correct date is "14-feb-2022".

Manufacturer Narrative

On (b)(6) 2022, biosense webster inc.Received additional information indicating the product code for this suspected device is d132705.It was reported the lot number is not available.Additionally, the product code for one of the concomitant products was provided as r7f282ct (7fr decan,11p,f,2.4mmle,282mm,).Based on the provided information, the following fields have been updated: d1.Brand name has been updated from ¿thermocool® smart touch¿ electrophysiology catheter¿ to ¿thermocool® smart touch¿ bi-directional navigation catheter¿.D2a.Common device name has been updated from ¿similar device d133601, pma # p030031/s053¿ to ¿cardiac ablation percutaneous catheter¿.D2b.Procode was updated from ¿unk¿ to ¿lpb¿.D4.Catalog has been updated from ¿unk_smart touch unidirectional¿ to ¿d132705¿.D10.Concomitant medical products has been updated from ¿unknown decanav catheter¿ to ¿7fr decan,11p,f,2.4mmle,282mm,¿ 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: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12973939
• MDR Text Key: 282032835
• Report Number: 2029046-2021-02151
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/15/2022

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 Model Number: D132705
• Device Catalogue Number: D132705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2021
• Initial Date FDA Received: 12/10/2021
• Supplement Dates Manufacturer Received: 12/21/2021; 02/14/2021; 03/15/2022
• Supplement Dates FDA Received: 01/10/2022; 03/15/2022; 03/16/2022
• 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: 7FR DECAN,11P,F,2.4MMLE,282MM,; CARTO 3 SYSTEM; UNKNOWN DECANAV CATHETER; UNKNOWN GENERATOR; UNKNOWN PUMP
• Patient Outcome(s): Life Threatening