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

Catalog Number	D132702
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	01/18/2018
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.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).
Event or Problem Description
It was reported that a patient underwent a pulmonary vein isolation (pvi) ablation procedure for atrial fibrillation with a thermocool smarttouch bidirectional sf catheter and suffered a cardiac tamponade requiring pericardiocentesis.Pre-procedure, a small pericardial effusion was noted via intracardiac echocardiography (ice).After transseptal puncture, heparin administration, and extensive mapping, to include difficult access to the left superior pulmonary vein (lspv), the pericardial effusion volume was noted to have increased.Pericardiocentesis was performed and yielded 140 ml of fluid.Remainder of procedure was aborted.Patient remained stable throughout.No ablation was performed.It was noted that the physician does not believe that a bwi product was responsible for the injury.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.
Additional Manufacturer Narrative
Additional information was received on february 7, 2018.The patient involved was female.The patient did not require extended hospitalization due to the event.Since the event the patient has fully recovered.The physician did not provide a causality opinion on the cause of the adverse event.However, it was noted that the patient had small pulmonary veins, which may have contributed to the event.A transseptal puncture was performed.The patient received heparin as an anticoagulant after transseptal puncture and the activated clotting time was maintained at 300-350 seconds.A st.Jude medical sl1 8fr sheath was used during the procedure.No radiofrequency was delivered during the procedure.It is unknown when the injury occurred.The flow rate was 2ml/min.There were no error messages observed on biosense webster equipment during the procedure.The smarttouch catheter was not in close proximity to another catheter.The catheter was not zeroed after the initial warm-up phase post catheter connection to the carto® 3 patient interface unity.The ablation catheter had not been used in procedure; it was introduced but not used.Manufacturer's ref.No: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7259603
• Report Number: 2029046-2018-01174
• Device Sequence Number: 13749460
• Product Code: LPB
• UDI-Device Identifier: 10846835009170
• UDI-Public: 10846835009170
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P030031/S053
• 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,Followup
• Report Date (Section B): 01/18/2018

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: 10/31/2018
• Device Catalogue Number: D132702
• Device Lot Number: 17755049M
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/18/2018
• Supplement Date Received by Manufacturer: 01/18/2018
• Initial Report FDA Received Date: 02/09/2018
• Supplement Report FDA Received Date: 03/01/2018
• 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