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

Model Number D134801

Device Problems Failure to Sense (1559); Patient Device Interaction Problem (4001)

Patient Problems Bradycardia (1751); Paralysis (1997); Perforation of Vessels (2135)

Event Date 02/16/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6).Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.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 male patient underwent an unknown ablation with a thermocool® smart touch® sf bi-directional navigation catheter and suffered diaphragmatic paralysis, bradycardia, artery injury requiring a pacemaker implant.When the smart touch sf catheter was connected, 105 sensor error occurred when svc ablation, diaphragmatic nerve disorder abdominal wall artery injury occurred.Connection was checked, the cable was changed, the issue was resolved by changing the catheter to another one after that, there was no abnormality with the product and the procedure was completed.Because bradycardia was also observed after stopping atrial fibrillation, pacemaker implant (pmi) was performed.Due to this, hospitalization was prolonged.The physician¿s opinion on the cause of this adverse event: not bwi product malfunction.The patient required extended hospitalization because of the adverse event.The patient required a pacemaker.A thermocool smarttouch sf catheter was used.On may 21, 2021, bwi received additional information indicating that 2 stsf were used for the procedure and the adverse event was found after the procedure.So we decided both of the stsf are possibly involved the adverse event.Based on this information both stsf catheters will be reported.Since the event is life threatening and required intervention and prolonged hospitalization 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: 11954168
• MDR Text Key: 254828911
• Report Number: 2029046-2021-00883
• 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: 05/21/2021

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 Model Number: D134801
• Device Catalogue Number: D134801
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/21/2021
• Initial Date FDA Received: 06/08/2021
• Was Device Evaluated by Manufacturer?: No
• 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 3 SYSTEM; UNSPECIFIED CATHETER CABLE
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention