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 06/29/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.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 (b)(6)-year-old male patient underwent an unknown ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered phrenic nerve paralysis.Phrenic nerve palsy occurred during superior vena cava (svc) ablation.The movement of the diaphragm became poor, but the patient was followed up.The physician commented that because it was a place with twitching, it was carefully ablated, but it was an obstacle.There were no problems with the biosense webster, inc.Products.This adverse event was discovered during use, or post use of biosense webster products.The physician¿s opinion on the cause of this adverse event: procedure.Phrenic nerve palsy occurred during svc ablation.The physician commented that because of the location of the twitching confirmed, it was ablated carefully, but phrenic nerve palsy occurred.Observation only.Patient was reported as improved.It was not reported extended hospitalization was required.

Manufacturer Narrative

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 30537310m number, 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
• MDR Report Key: 12225588
• MDR Text Key: 263417515
• Report Number: 2029046-2021-01182
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/29/2021

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: 04/05/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30537310M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/29/2021
• Initial Date FDA Received: 07/26/2021
• Supplement Dates Manufacturer Received: 09/02/2021
• Supplement Dates FDA Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK_SMARTABLATE GENERATOR.; UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Other
• Patient Age: 66 YR