MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number	BNI35FJCT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	10/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.A manufacturing record evaluation cannot be conducted because no lot number was provided by the customer.Manufacturer's ref # (b)(4).
Event or Problem Description
It was reported a (b)(6)-year-old-female patient underwent a right idiopathic ventricular fibrillation (idvt) ablation procedure with a thermocool® sf nav bi-directional catheter and the patient suffered a cardiac tamponade requiring pericardiocentesis.It was reported by the caller that at the end of the ablation procedure after the catheters were removed the patient¿s blood pressure dropped.A trans-thoracic echo was performed and is was observed that the patient had a pericardial effusion.A pericardiocentesis was performed in which 300 cc's was removed from the pericardial space.The drain was left in place and the patient was stabilized and transferred to the critical care unit (ccu) for observation.On 10/07/2019, biosense webster inc.Received additional information about the event and patient.The event was discovered post use of biosense webster products.The physician is unsure on the cause of this adverse event.The patient outcome is unknown.It is unknown if the patient required additional hospitalization.The patient was a 74 y/o female.It is unknown if transseptal was performed or the needle brand/model that was used.The event occurred after ablation was performed and after all catheters were removed.There was no evidence of steam pop.According to the cas the flow settings were as specified for the device.There were no error messages observed on biosense webster equipment during the procedure.The catheter was zeroed after the initial warm-up phase post catheter connection to the carto® 3 piu.Carto® 3 system did not indicate to re-zero the catheter.

• Brand Name: THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 9233170
• Report Number: 2029046-2019-03791
• Device Sequence Number: 2233412
• Product Code: LPB
• UDI-Device Identifier: 10846835003260
• UDI-Public: 10846835003260
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P030031/S025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/04/2019

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 Catalogue Number: BNI35FJCT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 10/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 74 YR