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

Catalog Number D134805

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/11/2019

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 30262212m number, and no internal actions related to the complaint was found during the review.Manufacturer's reference # (b)(4).

Event Description

This event is associated with a clinical trial, sponsored by biosense webster, inc.It was reported that a (b)(6) male patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered a cardiac tamponade requiring pericardiocentesis.At the end of the procedure, post ablation and post use of biosense webster, inc.Products, a cardiac tamponade was discovered and confirmed by intracardiac echocardiogram (ice).A pericardiocentesis was performed and 300 cc of fluid was removed from the pericardial space.The patient was reported to be in stable condition after pericardial drainage.Patient¿s outcome is fully recovered with no residual effects and was discharged the following day.Extended hospitalization was not required.The physician was not certain about the timing and the causality of the event and suggested that it can be procedure and/or patient condition related.No error messages were observed on any biosense webster, inc.Equipment during the procedure.Transseptal puncture was performed with a baylis standard curve transseptal needle (71cm) and a baylis nrg e hf 71 c0 transseptal needle.There was no evidence of a steam pop.Flow settings were set to standard flow rates, 2 ml/min and 15 ml/min.Force visualization features used were graph, dashboard, vector and visitag.Visitag parameters for stability used were range 3 mm, time 3 seconds, force over time 30%, tag size 3 gram, and lesion index value (surpoint).

• 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 drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 9379333
• MDR Text Key: 168242909
• Report Number: 2029046-2019-03938
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/11/2019

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: 07/22/2020
• Device Catalogue Number: D134805
• Device Lot Number: 30262212M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2019
• Initial Date FDA Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2019
• 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
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 85