MAUDE Adverse Event Report: BIOSENSE WEBSTER INC LASSO® NAV ECO VARIABLE CATHETER; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Model Number	D134301
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	04/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device investigation details: information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A 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 ref.# (b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient ((b)(6)) underwent an atrial fibrillation (afib) ablation procedure with a lasso® nav eco variable catheter and the patient suffered cardiac tamponade requiring a pericardiocentesis and surgical intervention.After mapping the heart the patient became hypotensive.A cardiac tamponade was noted by using ultrasound.A pericardiocentesis was performed and over 2000ml of fluid was withdrawn and then transfused.The patient was then sent to surgery.Biosense hardware worked within specifications and the caller does not request evaluation of hardware systems.The physician¿s opinion on the cause of the adverse event was the patient had very thin tissue in left atrial appendage (laa), the lasso pushed through it when the catheter fell into the appendage.The patient outcome was fully recovered (no residual effects).The patient had to go to cardiothoracic (ct) surgery and have the laa perforation closed.There was no ablation done prior to the hypotension and cardiac tamponade.The perforation was caused by the lasso catheter which was confirmed by the ct surgeon and ep doctor.A smartablate generator was used during this case.A transseptal puncture was performed with an abbott brk.Prior to noting the cardiac tamponade ablation was not performed.There was no evidence of steam pop.No error messages were observed on biosense webster equipment during the procedure.Force visualization features used were graph, dashboard, vector and visitag were enabled, ablation catheter was not responsible for the perforation though.

• Brand Name: LASSO® NAV ECO VARIABLE CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 14266683
• Report Number: 2029046-2022-00924
• Device Sequence Number: 19922148
• Product Code: DRF
• UDI-Device Identifier: 10846835009637
• UDI-Public: 10846835009637
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K113213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/01/2022

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
• Operator of Device: Health Professional
• Device Model Number: D134301
• Device Catalogue Number: D134301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 05/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 7FR DECAN,11P,D,2.4MMLE,282MM,; 8.5F SHEATH WITH CURVE VIZ LGC; ABBOTT BRK; CARTO 3 SYSTEM; SMARTABLATE GENERATOR KIT-US; SMARTABLATE PUMP KIT-US; SOUNDSTAR ECO SMS 8F CATHETER; THMCL SMTCH SF BID, TC, F-J
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 56 KG