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 Cardiac Tamponade (2226); No Code Available (3191)

Event Date 10/15/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Since no device has been received for analysis, 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.Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.The hemostatic valve separation malfunction reported under 2029046-2020-01697.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a male patient underwent cardiac ablation procedure for atrial fibrillation (afib) with thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring surgical intervention.In addition, a hemostatic valve separation issue occurred with the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.During the case the hemostatic valve on the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was leaking dark blood.The sheath was replaced, and the issue resolved.The event did not require percutaneous or surgical removal no other intervention to stop the bleeding.The hemodynamics was not compromised (several ml blood loss).It was also reported that a pericardial effusion was noticed as the patient's blood pressure dropped.The pericardial effusion was confirmed by ice.Caller reported that the medical intervention provided was a medication (ibutilide 10 mg and protamine 45 ml).The effusion got smaller and the pressure went up.The patient was reported to be in stable condition and the pressure is 109/ 66.Effusion was discovered during use of biosense webster products.Prior to effusion ablation of the cavotricuspid isthmus line was performed but the event occurred during mapping phase.Surgery was required immediately after the procedure was aborted.The final outcome is unknown.The caller did not have information about the need for extended hospital stay.They could only tell that the patient was set to stay overnight.Transseptal puncture was performed with baylis nrg needle.There was no evidence of steam pop.The irrigation flow was set to 2ml/min.No error messages were observed on biosense webster equipment during the procedure.Graph, dashboard, vector and visitag modules were used for force visualization.The visitag stability settings were set to 3 mm for 3 sec, fot25% at 3g.Respiration was used as additional visitag filter and tag index as prospective color option.The physician opinion is that the cause of the event was difficult transseptal puncture performed on the patient.Since the cardiac tamponade may be life threatening, it was assessed as mdr reportable under the thermocool® smart touch® sf bi-directional navigation catheter.The issue with the hemostatic valve was assessed as a mdr reportable malfunction hemostatic valve separation issue under the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.

• 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: 10832718
• MDR Text Key: 216180477
• Report Number: 2029046-2020-01696
• 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: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• 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: 10/15/2020
• 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): Life Threatening; Required Intervention