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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/16/2021

Event Type  Injury  

Manufacturer Narrative

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 a (b)(6) female patient underwent an idiopathic ventricular tachycardia (idvt) ablation with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade (ct) requiring pericardiocentesis.It was reported that during the procedure, while ablating in the rvot, the patient¿s blood pressure dropped.Through ultrasound, it was determined that there was a pericardial effusion (pe).A pericardiocentesis was performed with an unknown amount of fluid withdrawn.The patient stabilized.The following were used: carto (b)(4)generator (b)(4), pump (b)(4), along with catheter (b)(4).Reporter stated that the equipment worked within specifications and do not want them evaluated except for the catheter.Additional event information was received on (b)(6) 2021.It was reported that this adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event was that he thought he went too medial while he burned.Medical intervention provided was stat echo & pericardio centesis.The patient fully recovered with no residual effects.The patient required extended hospitalization because of the adverse event.She stayed two nights that were not expected, to ensure that she was fully recovered before letting her go home.A transseptal puncture was not performed.Prior to noting the pe or ct, an ablation was performed.There was no evidence of a steam pop that the physician was aware of.This event was noticed after the ablation phase.An irrigated catheter was used in the event and standard flow settings were used.The 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.Force visualization features used were: dashboard, vector, and visitag.The visitag module was used and the parameters for stability used were standard parameters, tag size=3.No additional filter used with the visitag.Color options used prospectively were fti.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

Event Description

It was reported that a (b)(6) female patient underwent an idiopathic ventricular tachycardia (idvt) ablation with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade (ct) requiring pericardiocentesis.It was reported that during the procedure, while ablating in the rvot, the patient¿s blood pressure dropped.Through ultrasound, it was determined that there was a pericardial effusion (pe).A pericardiocentesis was performed with an unknown amount of fluid withdrawn.The patient stabilized.The following were used: carto 11964 generator g4c-2405, pump g4cp-2468, along with catheter d134805 30634383l.Reporter stated that the equipment worked within specifications and do not want them evaluated except for the catheter.Additional event information was received on 17-nov-2021.It was reported that this adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event was that he thought he went too medial while he burned.Medical intervention provided was stat echo & pericardiocentesis.The patient fully recovered with no residual effects.The patient required extended hospitalization because of the adverse event.She stayed two nights that were not expected, to ensure that she was fully recovered before letting her go home.A transseptal puncture was not performed.Prior to noting the pe or ct, an ablation was performed.There was no evidence of a steam pop that the physician was aware of.This event was noticed after the ablation phase.An irrigated catheter was used in the event and standard flow settings were used.The 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.Force visualization features used were: dashboard, vector, and visitag.The visitag module was used and the parameters for stability used were standard parameters, tag size= 3.No additional filter used with the visitag.Color options used prospectively were fti.

Manufacturer Narrative

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 was performed for the finished device 30634383l 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).During an internal review on 16-dec-2021, it was noted that the physician¿s name and phone number were inadvertently omitted on the initial report.Therefore, the following fields were updated on this report:.

Manufacturer Narrative

The biosense webster inc.(bwi) product analysis lab received the device for evaluation on 05-jan-2022.The device evaluation was completed on 11-jan-2022.It was reported that a 74-year-old female patient underwent an idiopathic ventricular tachycardia (idvt) ablation with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade (ct) requiring pericardiocentesis.It was reported that during the procedure, while ablating in the rvot, the patient¿s blood pressure dropped.Through ultrasound, it was determined that there was a pericardial effusion (pe).A pericardiocentesis was performed with an unknown amount of fluid withdrawn.The patient stabilized.The following were used: carto 11964 generator g4c-2405, pump g4cp-2468, along with catheter d134805 30634383l.Reporter stated that the equipment worked within specifications and do not want them evaluated except for the catheter.Additional event information was received on 17-nov-2021.It was reported that this adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event was that he thought he went too medial while he burned.Medical intervention provided was stat echo & pericardiocentesis.The patient fully recovered with no residual effects.The patient required extended hospitalization because of the adverse event.She stayed two nights that were not expected, to ensure that she was fully recovered before letting her go home.The product was returned to biosense webster inc.(bwi) for evaluation.Bwi conducted a visual inspection and an evaluation of all features of the catheter.Visual analysis of the returned product revealed that no damage or anomalies were observed on the thermocool® smart touch® sf bi-directional navigation catheter.Per the event, several tests were performed.The magnetic, temperature and force features were tested, and no issues were observed.In addition, the product was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device 30634383l number, and no internal actions related to the complaint were found during the review.As part of bwi¿s quality process all catheters are manufactured, inspected, and released to approved specifications.No malfunction was observed during the product analysis.The instruction for use states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the catheter that could not be replicated during the analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• 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: 12980667
• MDR Text Key: 286143805
• Report Number: 2029046-2021-02164
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30634383L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2021
• 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: SMARTABLATE GENERATOR KIT-US; SMARTABLATE PUMP KIT-US; UNK_CARTO 3
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 74 YR
• Patient Sex: Female