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

Model Number D134805

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 06/19/2020

Event Type  Injury  

Manufacturer Narrative

"the device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because 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.(b)(4).

Event Description

It was reported that a (b)(6) year old, female patient with history of amyloidosis and cardiogenic shock underwent afib - paroxysmal ablation procedure with thermocool® smart touch® sf bi-directional navigation catheter and suffered arteriovenous (av) fistula requiring surgical intervention.It was reported that an av fistula was noticed after the sheaths were pulled post-procedure.The fistula was confirmed via vascular ultrasound.The caller stated that the patient was being sent for intervention.No other details were provided.The sheath was a short, non bwi.The ablation catheter was discarded after the procedure.The physician¿s opinion is that the cause of the event was procedure.Regarding the cause of the event was not provide.The patient¿s outcome had worsened.No extended hospitalization was reported.The generator was in power control mode.The system did not indicate to re-zero the catheter.Graph, dashboard, graph (taken from ct), vector, visitag were used for force visualization.Since the sheath was short the involvement of the ablation catheter cannot be excluded.The event will be conservatively reported under the ablation catheter.Visitag module was used with the recommended parameters.No additional filter was used with the visitag.Tag color was set by tag index.

• 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 drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10273468
• MDR Text Key: 199268719
• Report Number: 2029046-2020-00875
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 65 YR