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

Model Number D134702

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

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

Event Date 10/29/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a female patient ((b)(6)) underwent a cardiac ablation procedure for atrial fibrillation (afib) with a thermocool® smart touch® sf uni-directional navigation catheter and suffered cardiac tamponade requiring surgical intervention.It was reported that during an atrial fibrillation case, a pericardial effusion was noticed.The pericardial effusion was confirmed by intracardiac echo (ice).The caller reported that the medical intervention provided was a pericardiocentesis and an initial 150ml of fluid was removed.The caller stated that over 1000 ml of fluid was removed by the end of the case.The intervention included pericardiocentesis and surgical intervention to close a hole in/around the left atrial appendage.The patient¿s condition has improved.The patient was reported to be in stable condition and received a blood transfusion.The physician conducted an evaluation of the patient's condition with the surgery team.The patient had to stay in the hospital to recover from the surgical intervention and blood loss.As of (b)(6) 2020, the patient was still in the hospital.The adverse event was first discovered during the use of biosense webster products.The physician believes that the adverse event was caused by the procedure.The effusion was discovered after performing a double transseptal, with a lasso and a thermocool® smart touch® sf uni-directional navigation catheter, in the left atrium.It is thought that the second transseptal was more difficult and may have perforated the left atrial appendage with the baylis nrg needle.The transseptal puncture was performed with a baylis nrg transseptal needle.No ablation had been performed before noticing the effusion.The event occurred in the transseptal phase.An irrigated thermocool® smart touch® sf uni-directional navigation catheter was in the left atrium at the time of discovering the effusion.It had not been used for an ablation.The flow settings were at factory settings (2cc).The graph, dashboard and visitag were used in the procedure.The recommended visitag settings were used (3mm for 3 secs, 25% of the time with 3g of force, tag size was 3).The fti value was used for prospective color option.Since the thermocool® smart touch® sf uni-directional navigation catheter was inserted in the left atrium at the time of the event it is conservatively reported under this device.

• Brand Name: THERMOCOOL SMART TOUCH SF UNI-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 92618 ; 949789-868
• MDR Report Key: 10856247
• MDR Text Key: 217372031
• Report Number: 2029046-2020-01776
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: 10846835009781
• 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: Physician
• Type of Report: Initial
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134702
• Device Catalogue Number: D134702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2020
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 59