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

Model Number D134805

Device Problems Insufficient Cooling (1130); Patient Device Interaction Problem (4001)

Patient Problems Myocardial Infarction (1969); Stenosis (2263)

Event Date 04/28/2022

Event Type  Injury  

Event Description

It was reported that a male patient underwent a premature ventricular contraction (pvc) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf).The patient suffered a myocardial infarction, coronary artery stenosis requiring surgical intervention (cardiac catheterization procedure with intervention).During the pvc ablation right after ablation of the cusp with stsf, the temperature slightly increased and after that, blood pressure decreased.Imaging revealed stenosis of the left main trunk (lmt).The ablation procedure was interrupted, and the stenosis was treated, and the ablation was successfully completed.After that, the patient's condition stabilized, and the patient left the room.The patient was treated with a balloon or stent and left the catheter room in stable condition.The patient outcome of the adverse event was improved after percutaneous coronary intervention (pci).The generator used in the case was a smartablate with serial number unknown.No servicing for this equipment was needed.The ablation never continued beyond the cut-off value.The generator parameters were set on power control mode.

Manufacturer Narrative

Initial reporter phone: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number 30728817l and no internal action related to the complaint was found during the review.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Additional information was received on 30-may-2022.It was reported that the patient is 75 years old.Therefore, the a 2.Patient age at the time of event and a 2.Age unit were updated.The physician¿s name was provided.Therefore, e 1.Initial reporter title, e 1.Initial reporter first name, e 1.Initial reporter first name, e 2.Health professional, and e 3.Initial reporter occupation have been updated.This adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event is that it was procedure related.While the area near the aortic valve was ablated multiple times, ¿the ablation catheter entered into the lmt and ablated without being aware of it.Therefore, lmt was stenosed.¿ pci intervention was performed for lmt stenosis.Procedure was completed with the balloon catheter and the stent.The patient did require extended hospitalization because of the adverse event, it was presumed to observe the course of coronary artery stenosis.Therefore, h 6.Health effect - impact code has been updated.Clarification has been requested regarding statement that ¿the ablation catheter entered into the lmt and ablated without being aware of it.Therefore, lmt was stenosed.¿ if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Clarification on previously reported event was received on 11-jul-2022.The physician commented that the ablation catheter accidentally entered into the lmt (left main trunk of coronary artery).The physician did not notice that the catheter was in the lmt and ablation was performed in the lmt.The physician accidently ablated in the wrong area.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; 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14493452
• MDR Text Key: 292572363
• Report Number: 2029046-2022-01122
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/03/2022

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: 02/22/2023
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30728817L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2022
• Initial Date FDA Received: 05/25/2022
• Supplement Dates Manufacturer Received: 05/30/2022; 07/11/2022
• Supplement Dates FDA Received: 06/27/2022; 08/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2022
• 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: UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 75 YR
• Patient Sex: Male