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

Model Number D134805

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

Patient Problems Bradycardia (1751); No Code Available (3191)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6)."no code available" is being used to represent surgical intervention.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 patient underwent cardiac ablation procedure for atrial flutter (afl) with thermocool® smart touch® sf bi-directional navigation catheter and suffered sinus block requiring temporary pacemaker implantation.During mitral afl procedure, while ablation was conducted for anterior line with the stsf, the stimulus from the sinus disappeared and it became arrest [block].The cause is that the sinus node artery (sna) has been ablated.The patient was fitted with a temporary pacemaker and sent for follow up.At the time of leaving, there was little stimulation from sinus node.The physician¿s commented that there is no causal relationship with the product.There is a high possibility of temporary interruption due to the burning of sna.The sinus rhythm recovered the next day after returning to the ward and the patient fully recovered.Since this event may 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 (b)(6) 2020, bwi received additional information indicating that the patient is female (62kg).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

On 1/12/2021, the product investigation was completed as the complaint device was not returned.It was reported that a patient (female, 62kg) underwent cardiac ablation procedure for atrial flutter (afl) with thermocool® smart touch® sf bi-directional navigation catheter and suffered sinus block requiring temporary pacemaker implantation.During mitral afl procedure, while ablation was conducted for anterior line with thermocool® smart touch® sf bi-directional navigation catheter, the stimulus from sinus disappeared and it became arrest [block].The cause is that the sinus node artery (sna) has been ablated.The patient was fitted with temporary pacemaker and send for follow up.At the time of leaving, there was little stimulation from sinus node.The physician¿s commented that there is no causal relationship with the product.There is a high possibility of temporary interruption due to the burning of sna.The sinus rhythm recovered the next day after returning to the ward and the patient fully recovered.The code ¿bradycardia¿ is used for sinus block.Since there was no confirmation of sna stenosis.According to physician¿s opinion the cause of the event is procedure.The physician considered that the cause of the sinus arrest was that the sinus node artery was ablated on.The patient had fully recovered.When the patient left the catheter room, it was confirmed that the patient got little stimulation from the sinus.The stimulation from the sinus returned to normal the day after the patient returned to the ward, and it was considered that the patient recovered.The patient was followed with temporary pacing for about 1 week, extended hospitalization was required.Device investigation details: since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.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).

Manufacturer Narrative

On 5/27/2021, bwi received additional information indicating that the complaint device's lot number is 30419826m.Along with this information, the expiration date (8/18/2021) and the manufacture date (8/19/2020) became available.The lot number, expiration date, and manufacture date fields have been updated accordingly.A manufacturing record evaluation was performed for the finished device 30419826m 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 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: 10853548
• MDR Text Key: 217663091
• Report Number: 2029046-2020-01770
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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,Followup,Followup
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30419826M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO3 EXTERNAL REFPATCH; JPN CARTO3 SYSTEM; SMARTABLATE IRRIGATION TUBING; SOUNDSTAR ECO; VIZIGO SHEATH
• Patient Outcome(s): Required Intervention
• Patient Weight: 62