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

Model Number D134804

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/17/2020

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.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).

Event Description

It was reported that a male patient (73 year old) underwent cardiac ablation procedure for atrial flutter (afl) with thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.No blood pressure reading was noted on the cuff, and then intracardiac echo (ice) was used to discover the effusion.A pericardiocentesis was performed, with approximately 400 ml of fluid removed.Ablation was taking place in the atria and the left ventricle before the effusion was noted.No high force readings noted.No evidence of a steam pop.Procedure was completed at the time the effusion was discovered.The event discovered during use of biosense webster products.The patient¿s condition has improved.The transseptal was done with baylis needle.Max wattage used was 35w, and it is unknown how many ablation lesions were delivered.Visitag settings were: 1.5mm, 3 secs, 25% @ 3 grams.Force was visualized using the vector, dashboard, and graph.Standard irrigation settings.Fluid amount unknown.The visitags were colored using the tag index option.Physician¿s causality opinion is unknown.There was no report of extended hospitalization.Since cardiac tamponade may be life-threatening it is 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; 33 technology drive; 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: 11000554
• MDR Text Key: 221276133
• Report Number: 2029046-2020-01826
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; PENTARAY; SMARTABLATE GENERATOR; SOUNDSTAR; VISITAG; WEBSTER CS; WEBSTER DECA
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 73 YR