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 Paralysis (1997); Tachycardia (2095)

Event Date 06/10/2021

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.A manufacturing record evaluation was performed for the finished device 30527251m 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 that an unknown patient underwent a persistent atrial fibrillation (afib) ablation procedure using a thermocool¿ smart touch¿ sf bi-directional navigation catheter.The patient suffered phrenic nerve paralysis and tachycardia.During a persistent af, atrial tachardia(at) turned after pvi, and mapping ablation of roof, anterior, right atrial septum, etc., stopped tachycardia and ended the procedure.The patient also had phrenic nerve paralysis.The physician commented that it is unlikely that the phrenic nerve runs in the anatomy of the ablation site.The doctor said he did not know why the phrenic nerve paralysis developed.Since this event is life threatening and required interventions to prevent permanent impairment of a body function or permanent damage to a body structure, then 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: 12124287
• MDR Text Key: 264472843
• Report Number: 2029046-2021-01052
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2021

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: 03/18/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30527251M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/15/2021
• Initial Date FDA Received: 07/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2021
• 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