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

Model Number D132705

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/17/2021

Event Type  Injury  

Event Description

It was reported that a (b)(6) female patient underwent an unknown ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter.The patient suffered cardiac tamponade requiring pericardiocentesis.During a right ventricular ablation, the patient coughed leading to pericardial effusion.The physician drained the effusion, and the patient is stable and recovering well.It is unknown if the surgery was delayed or if the procedure was completed successfully due to the reported event.It is unknown if fragments were generated.There were patient status/ outcome / consequences.Patient consequence was pericardial effusion.It is unknown what other medical intervention was required.Additional information from note (b)(4) received on 03-dec-2021: product lot number: 30631081m.The adverse event occurred on (b)(6) 2021.This adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event is the patient condition- anatomy.Medical intervention provided was pericardial puncture.The patient outcome of the adverse event is fully recovered (no residual effects).The patient did require extended hospitalization because of the adverse event, one day longer for observation.Generator information: smartablate, g4c-6233.A transseptal puncture was not performed.Prior to noting the pe or ct ablation was performed.There was no evidence of steam pop.The event occurred post ablation phase.An irrigated catheter was used in the event, the flow settings were 30ml/min.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, the parameters for stability were 3s, 3mm, 25% -3g, size 3.No additional filters were used with the visitag.Color option used prospectively was time.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

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).

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 unknown ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter.The patient suffered cardiac tamponade requiring pericardiocentesis.During a right ventricular ablation, the patient coughed leading to pericardial effusion.The physician drained the effusion, and the patient is stable and recovering well.It is unknown if the surgery was delayed or if the procedure was completed successfully due to the reported event.It is unknown if fragments were generated.There were patient status/ outcome / consequences.Patient consequence was pericardial effusion.It is unknown what other medical intervention was required.Additional information from note (b)(4) received on 03-dec-2021: product lot number: 30631081m.The adverse event occurred on (b)(6) 2021.This adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event is the patient condition- anatomy.Medical intervention provided was pericardial puncture.The patient outcome of the adverse event is fully recovered (no residual effects).The patient did require extended hospitalization because of the adverse event, one day longer for observation.Generator information: smartablate, g4c-6233.A transseptal puncture was not performed.Prior to noting the pe or ct ablation was performed.There was no evidence of steam pop.The event occurred post ablation phase.An irrigated catheter was used in the event, the flow settings were 30ml/min.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, the parameters for stability were 3s, 3mm, 25% -3g, size 3.No additional filters were used with the visitag.Color option used prospectively was time.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

Manufacturer Narrative

On 18-jan-2022, the product investigation was completed as the complaint device was not returned.Device investigation details: 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 30631081m number, and no internal action related to the complaint was found during the review.If the device is received in the future, the complaint record will be reopened to perform the product investigation as appropriate.Complaint trends are monitored on a monthly basis as part of the company post market surveillance.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¿ 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: 12974293
• MDR Text Key: 285323963
• Report Number: 2029046-2021-02155
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2022

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: 09/02/2022
• Device Model Number: D132705
• Device Catalogue Number: D132705
• Device Lot Number: 30631081M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/01/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/03/2021
• 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