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

Model Number D134804

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/24/2021

Event Type  Injury  

Event Description

It was reported that an unknown patient underwent an atrial fibrillation (afib) thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade requiring pericardiocentesis and surgical intervention.During an afib case, a pericardial effusion was noticed as the patient's blood pressure and heart rate dropped.The pericardial effusion was confirmed by intracardiac echocardiography (ice).The medical intervention provided was a pericardiocentesis and 1410 cc of fluid was removed and they took him to the or and preformed a window.The patient was reported to be in stable condition.The physician stated that there was a steam pop on the flutter line and confirmed on ice the accumulation of fluid on ice.This adverse event was discovered post use of biosense webster products.The physician¿s opinion on the cause of this adverse event is the procedure.Medical intervention provided was pericardiocentesis and then a window in an or.The patient outcome of the adverse event is improved and stable.The medical staff does not believe that the patient required extended hospitalization due to this event as they were already planning to keep her overnight.Medical staff also believes that the patient had bmi of 19.Pa transseptal puncture was performed.Prior to noting the pe or ct an ablation was performed.An irrigated catheter was used in the event the correct flow settings were used.Correct catheter settings were selected on the generator.The pump was switching from ¿low¿ to ¿high¿ flow during ablation.No error messages were observed on biosense webster equipment during the procedure.The device was trashed during the event and is not available for return.Steam pop is not mdr-reportable.Since the event is life threatening and required cancellation of the procedure to prevent permanent impairment of a body function or permanent damage to a body structure, is to be considered serious and mdr-reportable.

Manufacturer Narrative

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 30644214l number, and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

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 30644214l number, and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that an unknown patient underwent an atrial fibrillation (afib) thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade requiring pericardiocentesis and surgical intervention.During an afib case, a pericardial effusion was noticed as the patient's blood pressure and heart rate dropped.The pericardial effusion was confirmed by intracardiac echocardiography (ice).The medical intervention provided was a pericardiocentesis and 1410 cc of fluid was removed and they took him to the or and preformed a window.The patient was reported to be in stable condition.The physician stated that there was a steam pop on the flutter line and confirmed on ice the accumulation of fluid on ice.This adverse event was discovered post use of biosense webster products.The physician¿s opinion on the cause of this adverse event is the procedure.Medical intervention provided was pericardiocentesis and then a window in an or.The patient outcome of the adverse event is improved and stable.The medical staff does not believe that the patient required extended hospitalization due to this event as they were already planning to keep her overnight.Medical staff also believes that the patient had bmi of 19.Pa transseptal puncture was performed.Prior to noting the pe or ct an ablation was performed.An irrigated catheter was used in the event the correct flow settings were used.Correct catheter settings were selected on the generator.The pump was switching from ¿low¿ to ¿high¿ flow during ablation.No error messages were observed on biosense webster equipment during the procedure.The device was trashed during the event and is not available for return.Steam pop is not mdr-reportable.Since the event is life threatening and required cancellation of the procedure to prevent permanent impairment of a body function or permanent damage to a body structure, is to be considered serious and mdr-reportable.

• 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: 13028990
• MDR Text Key: 286052180
• Report Number: 2029046-2021-02186
• 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: 12/17/2021

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: 09/17/2022
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30644214L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/24/2021
• Initial Date FDA Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2021
• 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
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Sex: Female