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

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

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

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

Event Date 01/27/2020

Event Type  Injury  

Manufacturer Narrative

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 manufacturer record evaluation cannot be conducted because the 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 (b)(6) male patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a thermocool smart touch sf bidirectional catheter and suffered a complete atrioventricular block/3rd degree heart block requiring permanent pacemaker implantation.It was reported that the carto 3 system showed a magnetic sensor error.The mapping cable was replaced and the issue did not resolve.The mapping catheter was replaced and the issue resolved.Per response received on 02/13/20, this was not a mapping catheter but a thermocool® smart touch® sf bi-directional navigation catheter.There were no further errors after catheter replacement and the case continued.This first issue of magnetic sensor issue with the thermocool® smart touch® sf bi-directional navigation catheter is not mdr reportable since the potential risk that it could cause or contribute to a serious injury or death is remote.The caller then stated that while ablating the cavo-tricuspid isthmus line (cti) line the second thermocool® smart touch® sf bi-directional navigation catheter was accidentally moved around the his bundle and the patient had complete atrioventricular block (a/v block).The patient was paced temporarily and was having a permanent pacemaker implanted.In the opinion of the physician the event was procedure related.The patient¿s condition was unchanged.The patient did not require additional hospital stay.Overall there were two (2) thermocool® smart touch® sf bi-directional navigation ablation catheters, one bwi sterilmed reprocessed cs catheter, one soundstar and a pentaray used in this procedure.The caller does not have the generator and pump serial number nor the catheter information for the second thermocool® smart touch® sf bi-directional navigation or biosense diagnostic catheters used.Caller also stated there was no issue with the second ablation catheter, hardware, or diagnostic catheters.The second ablation catheter, which had no defects or errors was in use at the time of the heart block together with the reprocessed cs and pentaray.

• Brand Name: 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 ; 33 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 9741928
• MDR Text Key: 191812563
• Report Number: 2029046-2020-00290
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/27/2020

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 Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/27/2020
• Initial Date FDA Received: 02/21/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention