MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D133602

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

Patient Problem Cardiac Tamponade (2226)

Event Date 11/07/2019

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 with lot number 30229285m, and no internal actions related to the reported complaint condition were identified.Manufacturer's reference # (b)(4).

Event Description

It was reported that a male patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and suffered a cardiac tamponade requiring pericardiocentesis.After the ablation phase, a cardiac tamponade was detected and pericardiocentesis was performed and an unknown amount of fluid was removed from the pericardial space.The physician noted that although the cardiac tamponade was discovered after the ablation phase, it could have occurred before.The procedure was delayed 20 minutes and was completed successfully.The patient was reported to be in stable condition after pericardial drainage.Patient¿s outcome is fully recovered with no residual effects.It is unknown if the patient required extended hospitalization.The physician¿s opinion on the cause of the event is that it was procedure related.No errors were observed on any biosense webster, inc.Equipment used during the procedure.A transseptal puncture was performed with a (b)(6) needle.A mullins sheath was also used.A biosense webster, inc.Pentaray catheter was used for mapping and validation.The patient received anticoagulant (unspecified) during the procedure.The generator was used in power control mode at 35-40 watts.The flow setting was set at 30 ml/min.The thermocool® smart touch¿ electrophysiology catheter was not in close proximity to another catheter and it was zeroed after the initial warm-up phase post catheter connection to the carto® 3 piu.The carto® 3 system did not indicate to re-zero the catheter.The force visualization features used during the procedure were graph, dashboard, vector and visitag force.No additional filters were used.The visitag parameters used was force greater than 3g 25%.The color option used prospectively was the ablation index.

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY 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: 9373588
• MDR Text Key: 168012444
• Report Number: 2029046-2019-03932
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009002
• UDI-Public: 10846835009002
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/07/2019

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: 05/28/2020
• Device Catalogue Number: D133602
• Device Lot Number: 30229285M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/07/2019
• Initial Date FDA Received: 11/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2019
• 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