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

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Air Embolism (1697); Ischemic Heart Disease (2493)

Event Date 01/20/2022

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 an unknown patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with an unknown smart touch bidirectional sf.The patient suffered air embolism and st elevation.It was reported that there were human errors during the procedure: the doctor first confused the stsf irrigation with the one for the pentaray.At the same time, the nurse didn't connect well the irrigation pipe (air entry on the line).Many bubbles leaked to the patient heart and provoked a critical st-segment elevation.Pump indicated bubbles error, which required the medical staff to change the tubulure 3 times.The problem came from the tubulures that present either opacity or spotted structures making difficult to ensure absence of bubbles.The recurrence of the problem was bothersome for the doctors because it forced them to remove catheters out of the patient for the flushing.Additional information: the event date the adverse event occurred (b)(6) 2022.The physician¿s opinion on the cause of this adverse event: bwi product malfunction.Patient outcome of the adverse event was reported as fully recovered (no residual effects).The patient did not require extended hospitalization because of the adverse event.The generator used in the case was a stockert gmbh, smartablate system rf generator ww.Force visualization features used graph, dashboard, vector & visitag with the visitag module parameters for stability: 3mm, 3 sec and respiration filter.Color options were used prospectively fti / ai.The patient has not exhibited any neurological symptoms since the procedure was completed.All of the 3 reported smartablate irr tube set (sat001) had the same cloudiness, pump error & embedded bubbles issues.Both stsf and the pentaray introduced air.The patient did not experience any other harms related to the air.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 11-feb-2022, the product investigation was completed as the complaint device was not returned.A photograph of the complaint device was also analyzed.It was reported that an unknown patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with an unknown smart touch bidirectional sf.The patient suffered air embolism and st elevation.It was reported that there were human errors during the procedure: the doctor first confused the stsf irrigation with the one for the pentaray.At the same time, the nurse didn't connect well the irrigation pipe (air entry on the line).Many bubbles leaked to the patient heart and provoked a critical st-segment elevation.Device investigation details: a picture showing a physiological saline bag and another picture showing electrocardiogram (ecg/ekg) signals were received for analysis.Even if the bubbles observed in the saline bag could be related to the event, the photos cannot provide sufficient information, and no conclusion can be obtained from them.Since no device has been received for analysis, 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.The instructions for use state that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.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: 13477560
• MDR Text Key: 288800932
• Report Number: 2029046-2022-00248
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/11/2022
• 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: CARTO 3 SYSTEM; PENTARAY NAV ECO; SMARTABLATE GENERATOR; SMARTABLATE TUBING; VISITAG MODULE
• Patient Outcome(s): Life Threatening; Required Intervention