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

Model Number D134801

Device Problems Low impedance (2285); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 05/19/2022

Event Type  Injury  

Event Description

It was reported that a (b)(6) year-old patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered cardiac tamponade requiring a pericardiocentesis.Atrial septal puncture was performed with using rf needle.Ablation was performed before the presence of the cardiac tamponade was confirmed.Steam pop was not confirmed.Irrigation catheter¿s flow rate setting were: = 30w: 10 ml, > 30w: 17 ml.Drainage was performed and the volume of fluid was minimal.The physician's opinions on the relationship between the event and the product was that impedance decreased during mitral isthmus (mi) ablation.The ablation may have caused the event and the procedure.The patient outcome of the adverse event was improved.The customer¿s reported issue of low impedance is not considered to be an mdr reportable malfunction since the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.

Manufacturer Narrative

Device investigation details: information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A device history record evaluation was performed for the finished device (b)(4) number, and no internal actions related to the complaint was found during the review.Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# pc-(b)(4).

Manufacturer Narrative

On 1-aug-2022, additional information was indicating a low impedance alarm was not reported.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14690962
• MDR Text Key: 294018116
• Report Number: 2029046-2022-01302
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• 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: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2023
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30735589L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2022
• 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: UNKNOWN TRANSSEPTAL RF NEEDLE
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 61 YR