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

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 10/11/2020

Event Type  Injury  

Manufacturer Narrative

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).

Event Description

It was reported that a patient underwent cardiac ablation procedure for atrial fibrillation (afib) with thermocool® smart touch® sf bi-directional navigation catheter and suffered thrombosis requiring unspecified intervention.During a redo afib procedure the thermocool® smart touch® sf bi-directional navigation catheter was intended to be used for both mapping and ablation purposes.However, during the ablation procedure the catheter flushed insufficiently.There was an impedance jump from 110 ohm to about 220 ohm during the ablation.Ablation was stopped immediately, and the catheter was removed from the body.The ablation cable was checked and replaced which did not resolve the issue.Thus when the catheter was changed, the map catheter was able to perform sufficient flushing.Blood clot was found at the catheter tip.The physician used the soundstar catheter to check if there were any effusion, and the procedure was continued and finished with a new thermocool® smart touch® sf bi-directional navigation catheter.Afterwards, the patient got blood clot and had to undergo further procedures to remove it.The procedure was able to continue without any complication reported.There was no report of extended hospitalization.The physician¿s causality pinion was not provided.The medical safety officer (mso) reviewed this event on 3/15/2021 and it was determined that the 2nd stsf catheter used cannot be excluded on the thrombosis occurrence; therefore this new report for the second complaint device was created in order to have the ¿thrombosis¿ event reported under both catheters, since both were used to ablate.Since thrombosis required medical intervention to preclude permanent impairment of a body function or permanent damage to a body structure it is mdr-reportable.This report is for the the initial catheter with the impedance and flushing issue had already been reported in manufacturer report number 2029046-2021-00001.

• 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: 11532869
• MDR Text Key: 241389107
• Report Number: 2029046-2021-00384
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2021

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 Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/15/2021
• Initial Date FDA Received: 03/19/2021
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention