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

Catalog Number D132705

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

Patient Problems Adult Respiratory Distress Syndrome (1696); Death (1802); Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Respiratory Tract Infection (2420)

Event Date 12/07/2017

Event Type  Death  

Manufacturer Narrative

Since the product was not returned for analysis as the customer is retaining the product, no product failure analysis can be conducted and no determination of possible contributing factors could be made.The manufacturing record evaluation (mre) review cannot be conducted because no lot number was provided by the customer.Manufacturer's ref.No: (b)(4).

Event Description

This event is associated with a clinical trial, sponsored by biosense webster, inc.Initially, the principal investigator assessed hypotension and dyspnea as not reportable as they were patient event non serious.In addition, the principal investigator assessed pneumonia and acute respiratory distress syndrome that resulted in the patient¿s non-cardiovascular death as not reportable as they were unrelated to the investigational device and unrelated to the procedure.Additional information was received on (b)(6) 2019 stating the principal investigator assessed pneumonia as not investigational device related and probably index procedure related.Also, acute respiratory distress syndrome that resulted in the patient¿s non-cardiovascular death as not investigational device related and possibly index procedure related.Therefore, for the adverse events of pneumonia, acute respiratory distress syndrome and death were assessed as mdr reportable.The awareness date for these reportable adverse events is (b)(4) 2019.It was reported that a (b)(6) female patient underwent an ablation procedure for paroxysmal atrial fibrillation with a thermocool® smart touch¿ bi-directional navigation catheter and suffered hypotension (requiring a new medication), dyspnea (requiring physiotherapy), pneumonia (requiring medication and mechanical ventilation) acute respiratory distress syndrome (requiring medication and mechanical ventilation) and death.On post-procedure day 3, the patient developed hypotension.An unspecified medication was administered.Issue is ongoing and improved.Principal investigator assessed this event as moderate in severity, not serious, not investigational device-related, and possibly index procedure-related.On post-procedure day 3, the patient developed dyspnea.Intervention was physiotherapy.Issue is ongoing and unchanged.Principal investigator assessed this event as moderate in severity, not serious, not investigational device-related, and possibly index procedure-related.On post-procedure day 8, the patient developed pneumonia.An unspecified medication was administered.Mechanical ventilation was also required.The patient required in-patient hospitalization.Issue is ongoing and worsened.Principal investigator assessed this event as severe, serious, not investigational device related and probably index procedure related.On post-procedure day 27, the patient developed acute respiratory distress syndrome.An unspecified medication was administered.Mechanical ventilation was also required.Extended hospitalization was required as a result of the adverse event.Patient¿s condition worsened, and the patient expired.Principal investigator assessed this event as severe, serious, not investigational device related and possibly index procedure related.

Manufacturer Narrative

Additional information was received on 4/10/2019 on the adverse event of acute respiratory distress syndrome stating this adverse event was anticipated.Manufacturer¿s reference number: (b)(4).

Manufacturer Narrative

An update was received on (b)(6) 2019 regarding the patient event outcomes.The patient events of hypotension, dyspnea and pneumonia were resolved with sequelae.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ 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: 8472051
• MDR Text Key: 140581018
• Report Number: 2029046-2019-02921
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2017

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: D132705
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2019
• Initial Date FDA Received: 04/01/2019
• Supplement Dates Manufacturer Received: 04/10/2019; 06/28/2019
• Supplement Dates FDA Received: 04/25/2019; 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention