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

Model Number D134801

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Paralysis (1997)

Event Date 06/03/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6).Additional information received indicates 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 30486065m 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).

Event Description

It was reported a male patient of unknown age underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter on (b)(6) 2021.The patient suffered phrenic nerve paralysis.The event occurred during use of biosense webster products.Right pulmonary vein (rpv) left pulmonary vein (lpv) ablated, at the beginning of lpv ablation, poor diaphragm movement was confirmed by fluoroscopy.The procedure was completed as usual.Phrenic nerve paralysis it was withdrawn as usual.There was a comment from the physician that an x-ray was taken before discharge.The physician commented that although the diaphragm was not anatomically confirmed at the site of rpv anterior wall ablation in this procedure, the physician pointed out the possibility that the patient's diaphragmatic running was unique.The physician commented that the patient's position of phrenic nerve was unusual.Since this event is life threatening and required surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure; is to be considered serious and mdr reportable.

• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12077425
• MDR Text Key: 258716055
• Report Number: 2029046-2021-00997
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2022
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30486065M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/03/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/10/2021
• 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
• Patient Outcome(s): Life Threatening; Required Intervention