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

Model Number D134804

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Tamponade (2226); No Code Available (3191)

Event Date 10/13/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The bwi product analysis lab received the device for evaluation on 10/26/2020.The device evaluation was completed on 11/9/2020.The device was visually inspected and it was found in good normal conditions.Per the complaint, several tests were performed.A deflection test was performed and the catheter was found within specifications.Also, sensor functionality was tested on the carto 3 system and no anomalies were observed.Then, stockert generator compatibility was tested and no temperature nor impedance issues were detected.Next to it, an electrical test was performed and no electrical malfunction was observed.Finally, catheter irrigation was tested and no irrigation issues were detected.A manufacturing record evaluation was performed for the finished device with lot number , and no internal actions related to the reported complaint condition were identified.The customer complaint regarding the adverse event cannot be duplicated as intended.The instructions for use states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.The device is working in specification.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a (b)(6) male patient with history of prior atrial fibrillation (afib) ablation procedure, left ventricle dysfunction and amiodarone, underwent an afib ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and pentaray nav high-density mapping eco catheter and suffered cardiac tamponade requiring pericardiocentesis and surgical intervention.Pericardial effusion was noticed after mapping and at the start of the ablation.The ultrasound and fluoro confirmed the effusion.Pericardiocentesis was performed to drain the fluid from the pericardial space.400 cc of blood were recycled back into the patient at first, nut then the pigtail catheter was connected to a vacutainer.Remainder of the procedure was aborted.The patient as then transferred to the operating room for a thoracotomy.The patient was moved to the intensive care unit and required prolonged hospitalization.Patient had fully recovered from the event.Physician¿s opinion regarding the cause of the adverse event is that it occurred due to catheter manipulation during mapping.Mapping was initially done with a pentaray nav high-density mapping eco catheter and then continued with the thermocool® smart touch® sf bi-directional navigation catheter.Transseptal puncture was performed with a bayless nrg needle.A total of 2 radiofrequency applications for 16 seconds were done.Default stsf irrigation settings (2ml/min) were used.The force visualization features used included graph and vector.The parameters of stability used with the visitag module were range 2mm and time 5 seconds.Impedance (0-10ohms) was used as coloring option.No bwi product malfunctions nor error messages were reported.Given the physician believes the issue occurred due to catheter manipulation during mapping, and the mapping was done with two different catheters (pentaray nav high-density mapping eco catheter and thermocool® smart touch® sf bi-directional navigation catheter) the event is being conservatively reported under both.

• Brand Name: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; 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 drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10824480
• MDR Text Key: 216627841
• Report Number: 2029046-2020-01673
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2021
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30407419M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Date Manufacturer Received: 10/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2020
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 57 YR