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

Catalog Number D134801

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Paralysis (1997)

Event Date 03/15/2024

Event Type  Injury  

Event Description

It was reported that a patient underwent a cardiac ablation and the patient experienced diaphragmatic nerve palsy.Ablation catheter pace was performed to confirm twitching.However, pacing could not be obtained, and the diaphragm was not moving.The diaphragm movement then returned, and the procedure was completed.This event occurred during superior vena cava isolation (svci) after box isolation with a cryo balloon, at the time of confirming twitching.The diaphragm temporarily stopped moving, but the movement was recovered, and the procedure was completed.The opinion (comment) of the doctor in charge about the relationship between this event and the product was that compound motor action potential (cmap) momentarily reduced during cryo, possibly caused by cryo.No additional intervention was provided.Patient improved.At this time, the event is being conservatively reported under the radiofrequency (rf) ablation catheter (thermocool® smart touch® sf bi-directional navigation catheter) and follow up is being conducted on whether rf ablation was delivered prior to the adverse event occurring.

Manufacturer Narrative

It was indicated that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number lot 31170262l 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.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).

Manufacturer Narrative

On 24-apr-2024, additional information was received which indicated that no radiofrequency (rf) ablation was done prior to the adverse event.As such, the cryo balloon (unknown brand/model) is the most suspected device as the event occurred during superior vena cava isolation (svci) after box isolation with the cryo balloon.Therefore, this event is no longer considered to be mdr reportable against the thermocool® smart touch® sf bi-directional navigation catheter.The h 6.Health effect - clinical code, h 6.Health effect - impact code, and h 6.Medical device problem code have been updated to reflect the changes.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: 19094586
• MDR Text Key: 339982009
• Report Number: 2029046-2024-01207
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134801
• Device Lot Number: 31170262L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2023
• 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: DEF, 7F, VARI, 10P, REDEL.; OCTA,LNG, 48P, 3-3-3-3-3, D-CURVE.; SOUNDSTAR ECO SMS 8F CATHETER.
• Patient Outcome(s): Other
• Patient Sex: Male