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

Model Number D134801

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Stenosis (2263); Heart Block (4444)

Event Date 02/10/2021

Event Type  Injury  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) and atrial tachycardia (at) ablation with a thermocool® smart touch® sf bi-directional navigation catheter and suffered heart block and was in junctional rhythm.The patient and physician are considering a pacemaker.It was reported that char occurred, the char was wiped but could not be removed, the issue was resolved by changing the catheter to another one.In the patient, both af (box isolation) and at (pac septum and anterior line) stopped due to ablation, and the patient was able to maintain sinus rhythm without any problem and without induction.While the sedation was stopped and hemostasis was being performed, the patient went into a junctional rhythm and sinus rhythm was no longer observed, but blood pressure was maintained, and the patient was discharged from the room.Additional information received indicates sinus rhythm has not recovered, but the patient also requests early discharge from the hospital, so they want to consider pacemaker.The physician stated the catheters after replacement with char may have affected heart block.The physician also stated that coronary ct was not performed in advance, and thus, the presence or absence of sinus artery disorder is unknown.It may be difficult to think that a thrombus formed and entered coronary and caused stenosis.In that case, other symptoms such as cerebral infarction should occur.Therefore, when creating the anterior line, they commented that the injury was more likely.

Manufacturer Narrative

On 3/18/2021, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

On (b)(6)2021, biosense received additional information indicating that the device which was in use at the time patient experienced the adverse event was the thermocool® smart touch® sf bi-directional navigation catheter with lot # 30467011m.As such, field d4.Lot has been updated with this information.In addition, it¿s been clarified that the catheter that had char was with lot # 30467014m.The issue of char is not considered to be mdr reportable since char is a physical phenomenon of radiofrequency ablation and can be a normal result of the ablation process.The presence of char does not by itself represent a serious injury, nor is it necessarily the result of a device malfunction.Additional information received indicates that the device suspected to be related to the adverse event, thermocool® smart touch® sf bi-directional navigation catheter with lot # 30467011m, is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Please disregard any previously reported product investigation details as they were not related to the reportable suspected device.A manufacturing record evaluation was performed for the finished device 30467011m 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 ref.# (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) and atrial tachycardia (at) ablation with a thermocool® smart touch® sf bi-directional navigation catheter and suffered heart block and was in junctional rhythm.It was reported that char occurred, the char was wiped but could not be removed, the issue was resolved by changing the catheter to another one.In the patient, both af (box isolation) and at (pac septum and anterior line) stopped due to ablation, and the patient was able to maintain sinus rhythm without any problem and without induction.While the sedation was stopped and hemostasis was being performed, the patient went into a junctional rhythm and sinus rhythm was no longer observed, but blood pressure was maintained, and the patient was discharged from the room.On 5/11/2021, biosense webster inc.Received additional information about the patient and event.The patient was male.It was confirmed that the type of heart block was junctional rhythm and a pacemaker was implanted.The patient has not exhibited any neurological symptoms since the procedure was completed.Patient outcome was reported as improved.The physician¿s opinion on the cause of this adverse event is that it was procedure related.The event occurred post use of bwi devices.The generator used in the case was a smartablate, as such, this device has been added.Concomitant med.Product section.Device evaluation details: the product was returned to biosense webster for evaluation and the evaluation was completed on (b)(6) 2021.Bwi conducted a general inspection through the visual inspection and all features of the catheter tests.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the thermocool® smart touch® sf bi-directional navigation catheter.Per the event, several tests were performed.The magnetic, temperature and force features were tested and no issues were observed.In addition, the product was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.No malfunction was observed during the product analysis.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).Manufacturer's ref.# (b)(4).

Manufacturer Narrative

As of today, multiple attempts have been made to obtain product returned status/availability with no response and the product has not been received.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) on 13-sep-2021, it was noticed that incorrect information was reported in supplemental (follow-up) medwatch report #3.The incorrect information is: "additional information received indicates that the device suspected to be related to the adverse event, thermocool® smart touch® sf bi-directional navigation catheter with lot # 30467011m, is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed." this information was incorrect because we had not received that information.The follow-up attempts for product returned status/availability were still in progress at the time of that mdr submission.

Manufacturer Narrative

On 7-sep-2022, additional information was received indicating this event is the same as the literature complaint reported to fda under manufacturer¿s ref # (b)(4) / manufacturer report number 2029046-2022-01319, as such, any other information or updates will be reported to fda under manufacturer¿s reference number: (b)(4) / manufacturer report number: 2029046-2021-00343.It was clarified that information previously reported in (b)(4), supplemental mdr # 2 which indicated pacemaker was implanted was incorrect, pacemaker implantation was only scheduled, not confirmed if it happened.Additional information identified under (b)(4) / manufacturer report number 2029046-2022-01319 not previously reported under this complaint include patient details such as the patient was a 66-year-old male patient who underwent a perimitral flutter (pmfl).Additional information obtained from the literature article includes the patient has history of three catheter ablations for paroxysmal afib.A few minutes after the final radiofrequency (rf) application, sinus rhythm disappeared, and junctional rhythm (heart block) appeared without significant st changes.Sedation was stopped dopamine infusion was started for bradycardia and hypotension; sinus rhythm did not return.In view of irregular sinus node function after 2 days, coronary computed tomographic angiography was performed, and it revealed occlusion of the sinus node artery (sna).Subsequently, percutaneous coronary intervention (pci) was performed to the occluded site of the sna.Snf recovered immediately after pci, allowing termination of the dopamine infusion.No bradycardia, sinus pause, or atrial tachyarrhythmia occurred after pci.Additionally, from the literature article, it was discovered a pentaray catheter was used during the procedure, as such, it has been added to the concomitant product section.Occlusion of sna has been coded as coronary artery stenosis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.#(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
• 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: 11457923
• MDR Text Key: 242028223
• Report Number: 2029046-2021-00343
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/06/2022

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: 11/02/2021
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30467011M
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/18/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/10/2021
• Initial Date FDA Received: 03/10/2021
• Supplement Dates Manufacturer Received: 03/18/2021; 04/15/2021; 06/01/2021; 09/13/2021; 09/07/2022
• Supplement Dates FDA Received: 04/12/2021; 05/13/2021; 06/21/2021; 09/15/2021; 10/06/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/03/2020
• 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: SMARTABLATE GENERATOR KIT-WW; UNK_PENTARAY; UNK_SMART TOUCH UNIDIRECTIONAL SF
• Patient Outcome(s): Other
• Patient Sex: Male