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

Catalog Number	BNI35BDH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Cardiac Tamponade (2226)
Date of Event	04/22/2019
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.As such the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device 30158051l number, and no internal action was found during the review.Manufacturer's ref.# (b)(4).
Event or Problem Description
It was reported that a (b)(6)-year-old female patient underwent an ablation procedure with a thermocool® sf nav bi-directional catheter and suffered cardiac tamponade (requiring pericardiocentesis) and vessel perforation.During the procedure, one (1) hour after the thermocool® sf nav bi-directional catheter had been in use, it was placed in the right ventricle outflow tract (rvot).It was then noticed the patient¿s blood pressure dropped to 40 units.Cardiac tamponade was confirmed by echo.Pericardiocentesis was performed to remove an unspecified amount of fluid from the pericardial space.There¿s no information regarding extended hospitalization.Patient¿s outcome is improved.Physician¿s opinion regarding the cause of the adverse event is that it was patient condition related.The physician commented there was no causal relationship between the biosense webster inc.(bwi) product and the adverse event.It was also reported that while using the thermocool® sf nav bi-directional catheter in the rvot, the impedance rose to 300 ohms and there¿s a possibility that the pulmonary artery (pa) was ruptured at that time.There is no information about medical/surgical intervention for the vessel rupture.No error messages were displayed on any bwi equipment during the case.Although the incidence of high impedance reading occurred, there is no indication that the impedance exceeded any impedance cut-off.As such, the issue of high impedance has been assessed as not mdr reportable.
Additional Manufacturer Narrative
On 5/14/2019, it was noticed that the patient information such as patient age at the time of event, age unit, sex, weight of the patient and weight unit were inadvertently omitted from the 3500a initial mdr transmitted to fda.The fields have now been populated.(69-year-old, female, weighing 48 kgs.).Manufacturer's ref # (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2019, additional information was received indicating a smartablate generator was used in the procedure on power control mode.The smarablate generator has been added to concomitant products.Manufacturer¿s ref # (b)(4).

• 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: 8609545
• Report Number: 2029046-2019-03143
• Device Sequence Number: 1998076
• Product Code: LPB
• UDI-Device Identifier: 10846835003154
• UDI-Public: 10846835003154
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030031/S025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/16/2019

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 Expiration Date: 12/09/2021
• Device Catalogue Number: BNI35BDH
• Device Lot Number: 30158051L
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 05/14/2019; 05/16/2019
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 05/14/2019; 06/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SMARTABLATE GENERATOR KIT-US
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 48