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 12/03/2020

Event Type  Injury  

Manufacturer Narrative

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.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 patient underwent a pulmonary vein isolation (pvi) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.The physician performed two transseptal punctures, one for the stsf catheter and another for the lasso catheter.The first transseptal puncture went well; however, the second transeptal puncture caused some issues, after the first try the physician could not aspirate any blood.A first echography imaging did not reveal anything at that time.After the mapping phase done with a lasso and during the ablation phase with a stsf, the patient¿s blood pressure dropped, and a second echography imaging revealed a small pericardial effusion.After a waiting time and as the patient was stable, the physician decided to continue the procedure.But after a second blood pressure drop and another more accurate echography performed by a specialist, the physician decided to stop the procedure and perform a pericardial puncture, which stabilized hemodynamically the patient.The patient left the room in a stable condition.It is unknown if extended hospitalization was required.Physician¿s opinion regarding the cause of the adverse event is that it occurred due to a difficult transseptal puncture.No bwi product malfunctions nor error messages were reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.This event is being conservatively reported under the stsf catheter since the cardiac tamponade was discovered after ablation had already applied; therefore, the bwi ablation catheter cannot be excluded.Since this event is life threatening and required 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 (b)(6) 2021, bwi received additional information regarding the event.Visitag module was used with a maximum distance change of 3 mm and a maximum time of 3 seconds.Respiration adjustment was used as additional filter with the visitag module, force over time (fot) was 25% and maximum force was 3 grams.Tag index was used as coloring option.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; 33 technology drive; irvine CA 92618
• MDR Report Key: 11062460
• MDR Text Key: 223800307
• Report Number: 2029046-2020-01981
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/03/2020

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
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 01/14/2021
• Supplement Dates FDA Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LASSO NAV; UNK_TRANSEPTAL NEEDLE
• Patient Outcome(s): Life Threatening; Required Intervention