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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Bradycardia (1751); Heart Block (4444)

Event Date 06/03/2022

Event Type  Injury  

Event Description

It was reported that a female patient (weighing 50kg) underwent an atrial tachycardia (at) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced heart block requiring a temporary pacemaker and has been scheduled for a permanent pacemaker.The event occurred when sinus and right atrial appendage (raa) were isolated after ablation line was created, atrial tachycardia (at) was stopped.A temporarily pacemaker was implanted and the patient left the room.There was sick sinus syndrome (sss), and the device was being considered because of ectopic sinus rhythm from before the procedure.The physician's opinions on the relationship between the event and the product is that there was no abnormality in the product.Past medical history includes sick sinus syndrome (sss),and had been considered for using a device.The patient has a history of treatment with atrial fibrillatin (afib) and atrial tachycardia (at), this was the 3rd ablation procedure.The physician¿s opinion on the cause of this adverse event is that there was no bwi product malfunction that occurred.Temporarily pacing was conducted.The patient was scheduled to have a pacemaker implanted at a later date.Before this procedure, a pacemaker was originally planned to be implanted.Ablation was planned after pacemaker placement, but at was found, and ablation treatment was prioritized.Complete disappearance of sinus node potential was caused by the ablation, but originally the patient's sinus node was not functioning well and the patient had an ectopic sinus rhythm.A smartablate generator was used during this case.

Manufacturer Narrative

Device investigation details: 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 device history record evaluation was performed for the finished device 30758591l number, and no internal actions related to the complaint was found during the review.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc., or its employees that the report constitutes an admission that the product, biosense webster inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Initial reporter phone: (b)(6).Manufacturer's ref.# (b)(4).

Manufacturer Narrative

On 4-jul-2022, biosense webster inc.Received additional information about the patient and event.It was reported the patient was an 81-year-old- female.It was also reported that although it was initially intended to implant a permanent pacemaker, the patient's condition, heart rate, and other parameters did not change from those before the study, and no pacemaker was implanted in the end.It was reported the patient fully recovered from the adverse event.The patient did not require extended hospitalization.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) correction: on 28-jul-2022, it was noticed incorrect coding was submitted the 3500a initial medwatch report under fields h6.Health effect - clinical code and h6.Health effect - impact code.The correct code has now been populated into those respective fields.H6.Health effect - clinical code was incorrectly reported as bradycardia (e060104) and has now been corrected to heart block (e060106) h6.Health effect - impact code was incorrectly reported as surgical intervention (f19) and how now been corrected to recognized device or procedural complication (f15) it was also noticed the physician details were inadvertently omitted from the 3500a initial medwatch report.The information has now been populated into the appropriate e1.Initial reporter fields.

• 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: 14877343
• MDR Text Key: 295068087
• Report Number: 2029046-2022-01485
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/28/2022

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: 03/15/2023
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30758591L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/03/2022
• Initial Date FDA Received: 06/30/2022
• Supplement Dates Manufacturer Received: 07/04/2022
• Supplement Dates FDA Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2022
• 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: 6FR CS,F,10 POLE,12 PIN,AUTOID.; PENTARAY NAV ECO 7FR, D, 2-6-2.; SMARTABLATE GEN. KIT (JAPAN).; SOUNDSTAR ECO SMS 8F CATHETER.
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 50 KG