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

Model Number D134805

Device Problems High Readings (2459); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/09/2021

Event Type  Injury  

Event Description

It was reported that a patient underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered cardiac tamponade requiring pericardiocentesis.During the isvt case, a pericardial effusion were noticed as the patient's blood pressure dropped.The pericardial effusion was confirmed by intracardiac echocardiography (ice).The medical intervention provided was a pericardiocentesis and 900 ml of fluid were removed.The physician believed their might of been a steam pop or maybe when he cardioverted that the rv catheter he may have pushed through.The patient was reported to be in stable condition.On 11-nov-2021, additional information was received indicating the adverse event was discovered during use of biosense webster products.The physician¿s opinion is that there was no definite conclusion on what caused the adverse event.Pericardiocentesis was provided as medical intervention.The patient outcome was reported as stabilized.Prior to noting the cardiac tamponade, ablation was already performed.There was an impedance spike and a pressure drop.The pressure drop occurred during the ablation phase and the effusion was discovered right after.The correct catheter settings were selected on the generator.The pump was not switching from ¿low¿ to ¿high¿ flow during ablation.

Manufacturer Narrative

Device investigation details: the device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30643034l number, and no non-conformances related to the complaint was found during the review.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, additional information was received indicating the impedance did not exceed the cut off value.The generator system was power controlled.The other information requested about noted temperature, impedance, and power is unavailable.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) on 19-jan-2022, it was noticed that the device manufacture date was inadvertently omitted from supplemental (follow-up) mdr # 1.As such, the date has now been added to field h4.Device manufacture date.

• Brand Name: THERMOCOOL® SMART TOUCH® SF 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: 12922146
• MDR Text Key: 281651431
• Report Number: 2029046-2021-02103
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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,Followup,Followup
• Report Date: 01/19/2022

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 Expiration Date: 09/22/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30643034L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 12/03/2021
• Supplement Dates Manufacturer Received: 12/21/2021; 01/19/2022
• Supplement Dates FDA Received: 01/19/2022; 01/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2021
• 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: UNKNOWN GENERATOR; UNKNOWN PUMP
• Patient Outcome(s): Life Threatening; Required Intervention