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

Model Number D134804

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

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

Event Date 08/14/2020

Event Type  Injury  

Manufacturer Narrative

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.(b)(4).Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.During the procedure the patient¿s blood pressure dropped, and pericardial effusion was discovered after completion of pulmonary vein isolation (pvi) when left atrium (la) roof line was attempted.No roof line done.Cardiac tamponade was confirmed by intracardiac echocardiography (ice).Pericardiocentesis was performed to remove 340 cc of fluid from the pericardial space.The patient was reported in stable condition after pericardial drainage.It is unknown if extended hospitalization was required as a result of the adverse event.Patient had fully recovered.The physician believes the perforation occurred in the right atrium (ra) because it was a slow leak that took time to build up, or at the cavotricuspid isthmus (cti) or coronary sinus (cs) and that the biosense webster cs catheter might have caused the complication as he usually uses a bard deca catheter in the coronary sinus (cs); however, the staff accidentally gave him a webster cs catheter.Transseptal puncture was performed with a baylis transseptal needle and an agilis sheath.The event most likely has occurred during fast anatomical mapping (fam) or ra and cti ablation.Default stsf flow settings were used.The force visualization features used included graph, dashboard and vector.The parameters for stability used were 2mm, 3sec, 25 %, 3 grams.Size 2 per physician¿s request.Ablation index was used prospectively as color option.No bwi product malfunctions nor error messages were reported.Since ablation was performed, the ablation catheter cannot be excluded as the contributing device to the adverse event.As such, the event is being reported only against the ablation catheter.There was no allegations of malfunction nor confirmation that the cs webster caused the injury; it was only described to be the physicians preference to use a bard deca catheter in the coronary sinus (cs).Follow up is in progress for additional clarification.If additional information/clarification is received, the information will be reviewed and event reassessed accordingly.

• 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: 10524520
• MDR Text Key: 207723733
• Report Number: 2029046-2020-01234
• 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: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2020
• 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): Life Threatening; Required Intervention