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 10/01/2020

Event Type  Injury  

Manufacturer Narrative

"no code available" is being used for surgical intervention.The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30416265l number, and no internal action related to the complaint was found during the review.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 male patient ((b)(6), 89kg) underwent cardiac ablation procedure for paroxysmal atrial fibrillation with thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring surgical intervention.After doing the transseptal (9:40 a.M.), the doctor checked the pericardium with transesophageal echo (eto).Then he went upwards with the thermocool® smart touch® sf bi-directional navigation catheter in the left atrium.Respiratory compensation was enabled and contact force "zeroed" (with some difficulty due to several intracardiac signals).The physician began anatomical mapping of the left atrium, particularly with the pulmonary veins using the ablation catheter.At around 10:10 am, the anesthesiologist reported a drop in the patient's blood pressure for approximately 5 minutes.After checking the trans-thoracic ultrasound, it turned out that there was blood in the pericardium, and a tamponade was confirmed.The patient was immediately taken care of by caregivers who performed pericardial drainage and managed to stabilize him.No ablation was performed.The event occurred during use of biosense webster products, during the mapping phase.No ablation was performed.The physician¿s opinion is that the cause of the event is procedure-related: the perforation of the left atrium appendage occurred when advancing the sheath and the ablation catheter in the left atrium, just after transseptal punction.The left atrium was small and the sheath was deep in the left atrial appendage (laa).3d anatomy of the left atrium was not reconstructed yet.Cardiac surgery had to be performed in order to close the wound of the laa.The patient recovered well from the surgery.Hospitalization was extended due to the need of surgery.All force visualization features were utilized.After the transseptal (needle : brk xs, st jude medical, ref : g407208, sheath : swartz, st jude medical, ref : 7566065), the pericardium has been verified by echography and everything was appeared fine.The irrigation settings were standard for (2ml/min).No error messages observed on biosense webster equipment during the procedure.Since cardiac tamponade may be life threatening it is mdr 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: 10742393
• MDR Text Key: 214154469
• Report Number: 2029046-2020-01553
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 10/01/2020

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 Expiration Date: 08/13/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30416265L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 10/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2020
• 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: 89