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 11/18/2021

Event Type  Injury  

Event Description

It was reported that an unknown patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade requiring pericardiocentesis.It was reported that during the atrial fibrillation procedure, a pericardial effusion was noticed in the patient.The crna noticed that there was a drop in blood pressure on the patient.The pericardial effusion was confirmed via ice, with the soundstar catheter.The caller reported that the medical intervention provided was a pericardiocentesis, and about 300ml of fluid was removed.The caller reported that the patient is in stable condition.It was also reported that the carto 3 system displayed a magnetic sensor error 6150, after the catheter was connected to the piu.The catheter connections were re-seated without resolution.The catheter was replaced, and the issue resolved.The procedure continued.The carto 3 system is operating per specs and is not responsible for the product issue.The physician¿s opinion on the cause of the adverse event is that he does not blame carto or any of the products used.The patient is in good condition.The patient outcome of the adverse event is fully recovered.A transseptal puncture was performed.Needle product details: baylis.Prior to noting the pe or ct ablation was performed.There was no evidence of steam pop.This event was noticed in the ablation phase.An irrigated catheter was used in the event, the flow settings were the normal ones for an stsf catheter.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 force graph, dashboard, vector, and visitag.The visitag module was used, the parameters for stability used were 3mm/3sec; 25% 3g.Additional filter used with the visitag was respiratory gated.Color options were used prospectively: fti.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 an unknown patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade requiring pericardiocentesis.It was reported that during the atrial fibrillation procedure, a pericardial effusion was noticed in the patient.The crna noticed that there was a drop in blood pressure on the patient.The pericardial effusion was confirmed via ice, with the soundstar catheter.The caller reported that the medical intervention provided was a pericardiocentesis, and about 300ml of fluid was removed.The caller reported that the patient is in stable condition.It was also reported that the carto 3 system displayed a magnetic sensor error 6150, after the catheter was connected to the piu.The catheter connections were re-seated without resolution.The catheter was replaced, and the issue resolved.The procedure continued.The carto 3 system is operating per specs and is not responsible for the product issue.The physician¿s opinion on the cause of the adverse event is that he does not blame carto or any of the products used.The patient is in good condition.The patient outcome of the adverse event is fully recovered.A transseptal puncture was performed.Needle product details: baylis.Prior to noting the pe or ct ablation was performed.There was no evidence of steam pop.This event was noticed in the ablation phase.An irrigated catheter was used in the event, the flow settings were the normal ones for an stsf catheter.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 force graph, dashboard, vector, and visitag.The visitag module was used, the parameters for stability used were 3mm/3sec; 25% 3g.Additional filter used with the visitag was respiratory gated.Color options were used prospectively: fti.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 7-dec-2021, the product investigation was completed as the complaint device was not returned.The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.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: 12954543
• MDR Text Key: 285249444
• Report Number: 2029046-2021-02117
• 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
• Report Date: 12/07/2021

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 Model Number: D134805
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2021
• Initial Date FDA Received: 12/07/2021
• Supplement Dates Manufacturer Received: 12/07/2021
• Supplement Dates FDA Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: No
• 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: BAYLIS TRANSSEPTAL NEEDLE; CARTO 3 SYSTEM; SOUNDSTAR ECO CATHETER; VISITAG MODULE
• Patient Outcome(s): Required Intervention; Life Threatening