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 Bradycardia (1751); Paralysis (1997)

Event Date 10/24/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(4).An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device number lot 30869259l and no non-conformances related to the complaint was found during the review.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a 51-year-old male patient weighing 62.0 kg and weighing 178.00 cms underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered diaphragmatic paralysis.It was reported that the procedure was a second procedure.Superior vena cava (svc) isolation was performed after left atrium (la) gap filling.Ablation was conducted clockwise from at posterior wall of lateral with the sup view.At the timing of conducting radiofrequency (rf) at anterior wall of lateral, the right diaphragm was elevated, and contractile dysfunction of the diaphragm was confirmed on fluoroscopy.The event occurred while performing svc isolation.There was no aggravation of respiratory condition during the procedure.The patient did not complain of dyspnea.The patient left from the room without apparent respiratory distress.The patient was followed up on.Adverse event: diaphragmatic nerve palsy.The physician's opinions on the relationship between the event and the product was that there is almost no relationship with the ¿jjkk¿ product.The physician was preoccupied with bradycardia during the procedure.At the same time, decided that diaphragmatic neuropathy would not occur and thought that he should have confirmed twitching.There were no abnormalities observed prior to use and during use of the product.Relevant medical history was none.The adverse event was discovered during use of biosense webster products.The patient fully recovered.The complaint product will not be returned for analysis.A smartablate generator was used, and the serial number was unknown.No further information is available.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

Additional event information was received 11-jan-2023.It was reported that the patient required extended hospitalization of 2 days for follow-up observation.Therefore, h 6.Health effect - impact code was updated.The physician¿s contact information was provided.Therefore, section e for initial reporter was updated.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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15846715
• MDR Text Key: 304169128
• Report Number: 2029046-2022-02911
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/30/2023

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 Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30869259L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2022
• Initial Date FDA Received: 11/22/2022
• Supplement Dates Manufacturer Received: 01/11/2023
• Supplement Dates FDA Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2022
• 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: UNK_SMARTABLATE GENERATOR.
• Patient Outcome(s): Life Threatening
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 62 KG