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

Model Number D134801

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Vasoconstriction (2126); No Code Available (3191)

Event Date 10/23/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 (b)(6) year old underwent cardiac ablation procedure for atrial fibrillation (afib) with thermocool® smart touch® sf bi-directional navigation catheter and suffered arterial spasm requiring surgical intervention.After a thermocool® smart touch® sf bi-directional navigation catheter was inserted, zeroing error 106 (force sensor issue) was presented.The issue was resolved by changing the catheter to another one.The procedure continued with ablating the posterior wall of the left atrium at only one point.The behavior of the contact force (cf) was normal.Box procedure, mitral, septal line, left atrium (la) lower wall line were added, and finally ablation in coronary sinus (cs) was performed.At that time st segment elevation and bradycardia occurred.When the right coronary artery was imaged with while pacing from the right ventricle (rv), stenosis was observed between electrodes #1 an #2.When preparing for coronary angiography, it was converted to ventricular fibrillation (vf), and after stopping vf by cardioversion the patient was placed on percutaneous cardiopulmonary support (pcps) was and the left coronary artery was imaged when circulation was secured.The left coronary artery was not clogged, and when the right coronary artery was imaged again, the stenosis was released, and it was found that the spasm was transient.The physician commented that the cause of the complications was unknown, and it cannot be said that there was no causal relationship with carto3 or smartablate (sa).The patient recovered consciousness and spontaneous breathing, and his condition is stable now.There was no report of extended hospitalization.The force issue is not mdr-reportable.However, since the arterial spasm required surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure it is mdr-reportable.

Manufacturer Narrative

On 1/20/2021, the product investigation was completed as the complaint device was not returned.After a thermocool® smart touch® sf bi-directional navigation catheter was inserted, when zeroing error 106 (force sensor issue) was presented.The issue was resolved by changing the catheter to another one.The procedure continued with ablating the posterior wall of the left atrium at only one point.The behavior of the contact force cf was normal.Box procedure, mitral, septal line, left atrium (la) lower wall line were added, and finally ablation in coronary sinus (cs) was performed.At that time st segment elevation and bradycardia occurred.When the right coronary artery was imaged with while pacing from the right ventricle (rv), stenosis was observed between electrodes #1 an #2.When preparing for coronary angiography, it was converted to ventricular fibrillation (vf), and after stopping vf by cardioversion the patient was placed on percutaneous cardiopulmonary support (pcps) was and the left coronary artery was imaged when circulation was secured.The left coronary artery was not clogged, and when the right coronary artery was imaged again, the stenosis was released, and it was found that the spasm was transient.Insert the swan ganz catheter and go to the ward.The physician commented that the cause of the complications was unknown, and it cannot be said that there was no causal relationship with carto3 or smartablate (sa).The patient recovered consciousness and spontaneous breathing, and his condition is stable now.There was no report of extended hospitalization.Device investigation details: since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.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.Manufacturer's reference number: (b)(4).

• 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
• MDR Report Key: 10837629
• MDR Text Key: 216195819
• Report Number: 2029046-2020-01691
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

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 Model Number: D134801
• Device Catalogue Number: D134801
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/13/2020
• Supplement Dates Manufacturer Received: 01/20/2021
• Supplement Dates FDA Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; SMARTABLATE GENERATOR; SMARTABLATE PUMP; THERMOCOOL SMARTTOUCH; CARTO 3 SYSTEM; SMARTABLATE GENERATOR; SMARTABLATE PUMP; THERMOCOOL SMARTTOUCH
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 47 YR