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

Model Number D134805

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Complete Heart Block (2627); No Code Available (3191)

Event Date 10/23/2020

Event Type  Injury  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

Event Description

It was reported that a male patient ((b)(6)- year old) underwent cardiac ablation procedure for idiopathic ventricular tachycardia (idvt) with thermocool(r) smart touch(r) sf bi-directional navigation catheter, and suffered complete heart block requiring surgical intervention.It was reported that after 2 seconds of radiofrequency (rf) during a premature ventricular contraction (pvc) ablation the patient went into complete heart block.The physician will be inserting a bi-ventricular (biv) pacemaker.The catheter will be returned for analysis.Patient was stable at the time of the call.Mapping of the pvc was performed in the aortic root and below the aortic valve in the left ventricle.Earliest activation of the pvc was determined.The his potentials were mapped and tagged.The are of earliest activation for the pvc did not display a his potential.Rf ablation was performed at the site of earliest pvc activation.Junctional rhythm was seen during ablation and the rf energy was turned off.Ablation time was approximately 2 seconds.Third degree heart block was seen after ablation was stopped.No further pvcs were seen.When the 3rd degree block did not resolve the patient was prepped for pacemaker.The physician considers procedure as the cause of the event.Pvc ablation was successful, therefore the patient condition has improved.Permanent pacemaker placement resulted in overnight stay, this may not have been an increase from the original intended care plan.

• Brand Name: WITH THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; 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 drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10853175
• MDR Text Key: 216662155
• Report Number: 2029046-2020-01747
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 90 YR