MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D133602

Device Problems High Readings (2459); Impedance Problem (2950); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 01/01/2021

Event Type  Injury  

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 (b)(4) number, and no internal action related to the complaint was found during the review.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 reference number: (b)(4).

Event Description

It was reported that a (b)(6) female underwent a premature ventricular contraction (pvc) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter.The patient suffered cardiac tamponade requiring pericardiocentesis.The medical staff performed electro-anatomical mapping of the right ventricle for a pvc procedure.During the procedure, the doctor performed a pace mapping with a thermocool smarttouch from the right outflow tract, at this stage it was therefore impossible to observe the impedance data from the ablation catheter even if the force sensor indicated a contact in the range (5-25 g ).When the stimulation was removed from the ablation catheter a high impedance was noticed on the rf generator.The operator was immediately alerted and they removed the catheter, echoed transthoracic, and noticed a slight pericardial tamponade.The pericardial tamponade was drained, the patient is out of danger and has been transferred in utic to be monitored.This adverse event discovered during use, or post use of biosense webster products.The physician¿s opinion on the cause of this adverse event: patient condition.Intervention provided: pericardiocentesis.Patient outcome: fully recovered.The patient did not require extended hospitalization because of the adverse event.Generator information: ep shuttle, stockert, (b)(4).A transseptal puncture was not performed.Prior to noting the ct ablation was not performed.No evidence of steam pop.The event occurred during mapping phase.An irrigated catheter was used in the event, what was the flow setting: thermocool st sf: 2ml (mapping phase), 8 &15 (ablation phase).No ablation was performed.High readings is not mdr-reportable.Impedance issue 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 (b)(4) number, and no internal action related to the complaint was found during the review.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 reference number: (b)(4).

Event Description

It was reported that a (b)(6) female underwent a premature ventricular contraction (pvc) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter.The patient suffered cardiac tamponade requiring pericardiocentesis.The medical staff performed electro-anatomical mapping of the right ventricle for a pvc procedure.During the procedure, the doctor performed a pace mapping with a thermocool smarttouch from the right outflow tract, at this stage it was therefore impossible to observe the impedance data from the ablation catheter even if the force sensor indicated a contact in the range (5-25 g ).When the stimulation was removed from the ablation catheter a high impedance was noticed on the rf generator.The operator was immediately alerted and they removed the catheter, echoed transthoracic, and noticed a slight pericardial tamponade.The pericardial tamponade was drained, the patient is out of danger and has been transferred in utic to be monitored.This adverse event discovered during use, or post use of biosense webster products.The physician¿s opinion on the cause of this adverse event: patient condition.Intervention provided: pericardiocentesis.Patient outcome: fully recovered.The patient did not require extended hospitalization because of the adverse event.Generator information: ep shuttle, stockert, st-0238.A transseptal puncture was not performed.Prior to noting the ct ablation was not performed.No evidence of steam pop.The event occurred during mapping phase.An irrigated catheter was used in the event, what was the flow setting: thermocool st sf: 2ml (mapping phase), 8 &15 (ablation phase).No ablation was performed.High readings is not mdr-reportable.Impedance issue 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¿ ELECTROPHYSIOLOGY 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: 12931868
• MDR Text Key: 285248244
• Report Number: 2029046-2021-02083
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009002
• UDI-Public: 10846835009002
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2022
• Device Model Number: D133602
• Device Catalogue Number: D133602
• Device Lot Number: 30546225M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2021
• 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: CARTO 3 SYSTEM.; EP SHUTTLE, STOCKERT.
• Patient Outcome(s): Required Intervention; Life Threatening