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 Paralysis (1997)

Event Date 04/25/2023

Event Type  Injury  

Manufacturer Narrative

E1 initial reporter phone:(b)(6).Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30985801l number, and no internal action 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.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 patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered diaphragmatic paralysis.It was reported that during the cryoablation of lipv (left inferior pulmonary vein), fluoroscopy confirmed that the left diaphragm was not moving properly.The right diaphragm was moving properly.Cryoablation was stopped.Timing was during cryoablation of lipv.The procedure was converted to rf ablation with the thermocool smarttouch sf.The soundstar eco and the pentaray nav sh were not inserted into the patient body during the cryoablation.The pulmonary vein isolation was completed using the thermocool smarttouch sf.Then the patient left the catheter room.Event: phrenic nerve palsy.Cf monitoring; dashboard, vector, visitag.Visitag coloring setting: tag index physician's comment on the relationship between this event and the product was that the issue was non-serious (moderate/minor).No causal relationship with bw products because the issue occurred during cryoablation with other company¿s cryo balloon catheter.The soundstar eco and the pentaray nav sh were outside the patient body during the cryoablation.There was no abnormality before using the product.Relevant medical history: none.The complaint product(s) will not be returned for analysis.Additional information- the adverse event was discovered during cryoablation, a transverse nerve injury occurred, at which time pentaray and soundstar were outside the body.Other relevant history ---none.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 6-jul-2023, bwi received additional information indicating that the event is not reportable under any bwi product.The received information confirms the following: that no ablation was performed with the stsf catheter.During cryoablation, a transverse nerve injury occurred, at which time pentaray and soundstar were outside the body.Since no bwi products were involved in the incident, this event has been assessed as not reportable.No further reports will be sent regarding this event.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: 16989181
• MDR Text Key: 315830959
• Report Number: 2029046-2023-01128
• 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: 08/03/2023

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: 30985801L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2023
• Initial Date FDA Received: 05/23/2023
• Supplement Dates Manufacturer Received: 07/06/2023
• Supplement Dates FDA Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/16/2023
• 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; CARTO VISITAG MODULE; PENTARAY CATHETER; SOUNDSTAR
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 57 KG