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

Model Number	D134703
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	09/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Event or Problem Description
It was reported that a 67-year-old female patient (170 lbs) underwent an atrial fibrillation (afib) ablation procedure with thermocool® smart touch® sf uni-directional navigation catheter and the patient suffered cardiac tamponade requiring pericardiocentesis.It was reported that the device was burning on the roof and physician felt a pop.Afterwards a pericardial effusion started forming and then immediately they performed a pericardiocentesis.The physician didn¿t specify on what their opinion was regarding the cause of this adverse event but did not blame the catheter.There were no product issues before the adverse event.Patient was stable after pericardial effusion.The patients¿ symptoms improved.Patient was sent to a recovery unit post case - unsure how long duration of stay.A smartablate generator was used in the event with the correct catheter settings selected on the smartablate generator.The pump was switching from ¿low¿ to ¿high¿ flow during ablation.A baylis needle was used for transseptal puncture.The event occurred during the ablation phase.An irrigated catheter was used in the event, the flow setting was high 15no error messages were observed on biosense webster equipment during the procedure.The catheter is available for return.
Additional Manufacturer Narrative
On 11-oct-2022, additional information was received indicating the cardiac tamponade occurred during ablation while burning in the posterior wall.Effusion was observed after the physician felt a pop and verified with ice imaging.Additionally, an updated lot number was received.As such, field d4.Lot has been updated from the number previously reported 307912254l to 30791254l.The manufactured date and expiration date have also been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated.Device investigation details: the device investigation has been completed which included performing a manufacturing record evaluation (mre).The manufacturing record evaluation performed for the finished device with lot number 30791254l identified no internal actions related to the reported complaint condition during the review.Still no device has been received for analysis, as such, no product investigation can be performed, and the customer complaint cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Additional Manufacturer Narrative
It was reported that a 67-year-old female patient (170 lbs) underwent an atrial fibrillation (afib) ablation procedure with thermocool® smart touch® sf uni-directional navigation catheter and the patient suffered cardiac tamponade requiring pericardiocentesis.It was reported that the device was burning on the roof and physician felt a pop.Afterwards a pericardial effusion started forming and then immediately they performed a pericardiocentesis.The physician didn¿t specify on what their opinion was regarding the cause of this adverse event but did not blame the catheter.There were no product issues before the adverse event.Patient was stable after pericardial effusion.The patients¿ symptoms improved.Patient was sent to a recovery unit post case - unsure how long duration of stay.Device investigation details: the device investigation has been completed which included performing a manufacturing record evaluation (mre).The manufacturing record evaluation performed for the finished device with lot number 30791254l identified no internal actions related to the reported complaint condition.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.However, if the product is received at a later date, the investigation will be updated as applicable.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® SF UNI-DIRECTIONAL NAVIGATION CATHETER
• Common Device Name: 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 ; 646591-7981
• MDR Report Key: 15524210
• Report Number: 2029046-2022-02361
• Device Sequence Number: 16777368
• Product Code: LPB
• UDI-Device Identifier: 10846835009798
• UDI-Public: 10846835009798
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2025
• Device Model Number: D134703
• Device Catalogue Number: D134703
• Device Lot Number: 30791254L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2022
• Supplement Date Received by Manufacturer: 10/11/2022; 05/25/2023
• Initial Report FDA Received Date: 10/01/2022
• Supplement Report FDA Received Date: 11/23/2022; 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BAYLIS C1 71CM TRANSSEPTAL NEEDLE; CARTO 3 SYSTEM; SMARTABLATE GENERATOR KIT-US; SMARTABLATE PUMP KIT-US
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 77 KG