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 12/03/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a premature ventricular contraction (pvc) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade requiring pericardiocentesis.Thermocool® smart touch® sf bi-directional navigation catheter was used in a pvc procedure at the right ventricle outflow tract.Although there were no vital signs such as decreased blood pressure during the operation, a small amount of pericardial effusion was confirmed by post-operative echography, and drainage was performed.There was no abnormality in johnson & johnson products such as thermocool® smart touch® sf bi-directional navigation catheter.There is no information about the hospitalization.The physician did not provide a causality opinion for the cause of this adverse event.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

Manufacturer Narrative

Additional information was received on 17-feb-2022: the patient is female.This adverse event was discovered post use of biosense webster products.Prior to noting the cardiac tamponade, ablation was performed.There was no evidence of steam pop.No error messages were observed on biosense webster equipment during the procedure.Therefore, updated ¿a3.Gender¿ field.In addition, the physician information was provided.Therefore, updated section ¿e.Initial reporter¿.Additional information was received on 10-mar-2022.The physician¿s opinion on the cause of this adverse event was not related with the biosense webster inc.Product malfunction but was related with the patient condition.The patient outcome of the adverse event was fully recovered.The patient did not require extended hospitalization because of the adverse event.The generator used in the case was a smartablate.The event occurred after hemostasis.The correct catheter settings were selected on the generator and the pump was switching from low to high flow during ablation.Force visualization features used were real time graph with force time intervel (fti) as an additional filter and tag index was used as the color options were used prospectively.Therefore, updated ¿d10.Concomitant medical products and therapy dates¿ field.In addition, the lot number was provided.Therefore, updated fields ¿d4.Catalog¿, ¿d4.Lot¿, ¿d4.Expiration date¿, ¿d4.Unique identifier( udi)¿ and ¿h4.Device manufacture date¿.Additional information was received on the event on 14-mar-2022, after the procedure, the patient recovered on the following day and was able to talk.The patient was already discharged from the hospital.There is no causal relationship with the product.The opinion that it may have been somewhat accumulated from before.The investigation was completed on 14-mar-2022.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 30609906l number, and no internal actions related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Additional information was received on 07-apr-2022 providing an additional concomitant product.Therefore, processed d10.Concomitant medical products and therapy dates field.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; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13091254
• MDR Text Key: 285173081
• Report Number: 2029046-2021-02255
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2022

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: 09/02/2022
• Device Model Number: D134805
• Device Catalogue Number: D134801
• Device Lot Number: 30609906L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/27/2021
• Supplement Dates Manufacturer Received: 02/17/2022; 04/07/2022
• Supplement Dates FDA Received: 03/17/2022; 04/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2021
• 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: 8.5F SHEATH WITH CURVE VIZ SMC; UNKNOWN BRAND PUMP; UNK_CARTO 3; UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Female