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

Catalog Number D134804

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

Patient Problems Thrombosis (2100); No Code Available (3191)

Event Date 03/09/2019

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.  if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.The manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.Concomitant product: vizigo sheath; us catalog #: unknown; lot #: unknown.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and developed thrombosis and thrombocytopenia requiring no medical interventions.During the procedure, after the physician gave heparin, he could see clots forming in the right atrium on intracardiac echo (ice).The patient tested positive for heparin induced thrombocytopenia and thrombosis (hitt), and the physician stopped giving heparin.The patient was reported to be in stable condition, no medical/surgical intervention was provided.They did not proceed with the left side.Reminder of the procedure was aborted.The biosense webster, inc.Products that were in use at the time of the event were a thermocool® smart touch® sf bi-directional navigation catheter and vizigo sheath.There is no information about the hospitalization.There¿s no information regarding the physician¿s causality opinion; however, this event has been reviewed with the biosense webster, inc.Medical safety officer and it was determined the issue was most likely procedure-related as that is the reason the patient received heparin.Not associated with biosense webster, inc.Products.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

• 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 ; 33 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8458828
• MDR Text Key: 140121199
• Report Number: 2029046-2019-02887
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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: 03/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134804
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/09/2019
• 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): Life Threatening