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 Problems Respiratory Failure (2484); Heart Failure/Congestive Heart Failure (4446)

Event Date 06/25/2022

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.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc.Or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 55-year-old male patient (78kg) underwent an atrial fibrillation (afib) ablation procedure with an unknown smart touch bidirectional sf.The patient suffered cardiac and respiratory failure post procedure requiring prolonged hospitalization and non-invasive ventilation.The ablation was performed for afib was completed and about three hours after the patient returned to the room, cardiac failure worsened.The patient was transferred to the intensive care unit (icu) and non-invasive positive pressure ventilation (nppv) respiratory management was performed.The patient felt difficulty in breathing, and spo2 decreased was confirmed and no cardiac tamponade was confirmed by echocardiography.As cardiac failure aggravated, diuretic was administered and nppv was attached.The physician's opinions on the relationship between the event and the product: as the patient originally had a tendency toward cardiac failure and vt (patient with icd implantation), fluid replacement and anesthesia during ablation were considered to have affected the cause.I do not think it is related to the product.Medical history/treatment history/other diseases currently being treated: vt abl was performed in 2018 (vt patient: icd implantation) and persistent atrial fibrillation.The adverse event was discovered post use of biosense webster products.The patient required extended hospitalization because of the adverse event.The generator used was a smartablate.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical 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 8-aug-2022, bwi received additional information regarding the event.The adverse event occurred on 25-jun-2022.The patient was discharged.Additional research was conducted regarding relevant tests and labs, but no further information was obtained.The lot number of the complaint device was also provided.The lot is 30749538l.The catalog number is d134805.The device is a thermocool® smart touch® sf bi-directional navigation catheter.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

On 7-sep-2022, the product investigation was updated and re-completed.A manufacturing record evaluation was performed for the finished device number 30749538l and no internal action 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).

• 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: 15036881
• MDR Text Key: 296044788
• Report Number: 2029046-2022-01638
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2023
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30749538L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/16/2022
• 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: CARTO 3 SYSTEM.; SMARTABLATE GENERATOR.
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 78 KG