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

Catalog Number D134805

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

Patient Problem Injury (2348)

Event Date 06/27/2019

Event Type  Injury  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation cannot be conducted because no lot number was provided by the customer.(b)(6).Manufacturer's ref.# (b)(4).

Event Description

It was reported that a (b)(6) male patient ((b)(6)) underwent an atrial fibrillation (afib) ablation procedure on (b)(6) 2019 with a thermocool® smart touch® sf bi-directional navigation catheter with no immediate patient consequences.It was initially reported that on post-procedure day 2 ((b)(6) 2019), the (b)(6) male patient developed symptoms of gastric dilation and hematemesis.No further details were provided regarding hospitalization, medical intervention, or patient outcome.As such, the event was initially assessed to be not mdr reportable.On (b)(6) 2019, additional information was received indicating the patient required medical intervention of a blood transfusion.It is unknown if extended hospitalization was required.Patient¿s outcome is improved.Physician¿s opinion regarding the cause of the patient event is that it was procedure-related.About gastric dilation, the possibility of esophageal neuropathy due to ablation of the left atrium posterior wall is predicted.The physician commented that no bwi product malfunctions occurred during the case.The generator was used in power control mode.No error messages were observed on any bwi equipment.This event was originally considered non-reportable, however, bwi became aware of additional information about the patient and event on (b)(6) 2019 and has reassessed this complaint as reportable.

• 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: 8991447
• MDR Text Key: 161229172
• Report Number: 2029046-2019-03620
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2019
• 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): Other; Required Intervention