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 11/10/2021

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.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 male patient underwent an afib paroxysmal procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf) and suffered cardiac tamponade (ct) requiring pericardiocentesis.It was reported that an afib ablation was performed.The kit involved was a medium curve vizigo bidirectional sheath, a nav stsf df curve ablation catheter, a decanav mapping catheter, a lasso eco 2-6-2 mapping catheter and ref patches.A brk xs needle and sl1 sheath was used for transseptal puncture.According to the reporter, the transseptal puncture was unremarkable.The pulmonary vein isolation (pvi) was completed, followed by a cavotricuspid isthmus (cti), a roof line and mitral line.The procedure was unremarkable, and all equipment worked without any issues.No errors were observed during the case.Post procedure, the patient became slightly hypotensive (90/50mm hg compared to baseline) despite giving adrenaline and fluids.Echocardiography confirmed a small rv free wall effusion with a residual lv effusion.A pericardiocentesis was subsequently performed.The patient was stable, and no other post procedural events occurred.The patient fully recovered.No extended hospitalization was required.The patient did not experience a post-op device malfunction.It is unknown if the patient experienced an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing.The patient did not require revision surgery or hardware removal.The patient is not part of a clinical study.Prior to noting the pe or ct ablation was performed.There was no evidence of a steam pop.An irrigated catheter was used in the event, the flow settings were as per instructions for use for thermocool stsf settings.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 the biosense webster equipment during the procedure.Force visualization features used were: graph, dashboard, vector, & visitag.The visitag module was used, the parameters for stability used were surpoint settings 450 posterior, 550 anterior.No additional filter used with the visitag.No color options were used prospectively.Since the event (ct) is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure and it required 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

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 30616855l 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 a male patient underwent an afib paroxysmal procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf) and suffered cardiac tamponade (ct) requiring pericardiocentesis.It was reported that an afib ablation was performed.The kit involved was a medium curve vizigo bidirectional sheath, a nav stsf df curve ablation catheter, a decanav mapping catheter, a lasso eco 2-6-2 mapping catheter and ref patches.A brk xs needle and sl1 sheath was used for transseptal puncture.According to the reporter, the transseptal puncture was unremarkable.The pulmonary vein isolation (pvi) was completed, followed by a cavotricuspid isthmus (cti), a roof line and mitral line.The procedure was unremarkable, and all equipment worked without any issues.No errors were observed during the case.Post procedure, the patient became slightly hypotensive (90/50mm hg compared to baseline) despite giving adrenaline and fluids.Echocardiography confirmed a small rv free wall effusion with a residual lv effusion.A pericardiocentesis was subsequently performed.The patient was stable, and no other post procedural events occurred.The patient fully recovered.No extended hospitalization was required.The patient did not experience a post-op device malfunction.It is unknown if the patient experienced an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing.The patient did not require revision surgery or hardware removal.The patient is not part of a clinical study.Prior to noting the pe or ct ablation was performed.There was no evidence of a steam pop.An irrigated catheter was used in the event, the flow settings were as per instructions for use for thermocool stsf settings.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 the biosense webster equipment during the procedure.Force visualization features used were: graph, dashboard, vector, & visitag.The visitag module was used, the parameters for stability used were surpoint settings 450 posterior, 550 anterior.No additional filter used with the visitag.No color options were used prospectively.Since the event (ct) is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure and it required 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.

• 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: 12921791
• MDR Text Key: 285247792
• Report Number: 2029046-2021-02101
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P030031
• 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: 12/02/2021

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: 08/16/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30616855L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2021
• 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: 8.5F SHEATH WITH CURVE VIZ MDC.; CARTO3 EXTERNAL REFPATCH 6PACK.; UNK BRK XS NEEDLE.; UNK DECANAV CATHETER.; UNK LASSO ECO 2-6-2 MAPPING CATHETER.; UNK SL1 SHEATH.; UNK THERMOCOOL® SMARTTOUCH® SF NAV CATHETER.
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Male