MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	D-1336-03-S
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)
Date of Event	11/09/2016
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.Concomitant medical products: lasso nav catheter (model# unknown lot# unknown); carto 3 system (model# unknown serial# unknown).(b)(4).
Event or Problem Description
It was reported that a male patient underwent a pulmonary vein isolation (pvi) ablation procedure for atrial fibrillation with a thermocool® smarttouch® uni-directional navigation catheter and suffered a cardiac tamponade requiring pericardiocentesis.Pre-procedure, it was noted that patient had a small, pre-existing pericardial effusion.While ablating in the left atrium near the right pulmonary veins, the patient became hypotensive.The small pre-existing effusion had grown significantly larger and a tamponade was confirmed via intracardiac echocardiogram.A pericardiocentesis was performed and yielded an unknown amount of fluid.The patient was reported to be in stable condition following the pericardiocentesis.Remainder of procedure was aborted.The patient was under observation at the time this complaint was report to biosense webster inc.(bwi).There is no information regarding extended hospitalization or patient outcome.There were no patient factors cited that may have contributed to the adverse event.Physician did not provide a causality opinion.However, it was noted that there was no evidence that it was caused by any bwi products.Transseptal puncture was performed with an unspecified needle.The patient received anticoagulant during the procedure with activated clotting times maintained in an unknown range.The smarttouch catheter was in close proximity to the lasso nav catheter.The smarttouch catheter was zeroed after the initial warm-up phase, post-connection to the carto 3 piu.Carto 3 system did not indicate to re-zero the catheter.There were no errors reported on any bwi equipment during the procedure.

• Brand Name: THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• MDR Report Key: 6151214
• Report Number: 9673241-2016-00842
• Device Sequence Number: 708813
• Product Code: LPB
• UDI-Device Identifier: 10846835009019
• UDI-Public: (01)10846835009019(11)160803(17)170731(10)17531106M
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 11/09/2016

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: 07/31/2017
• Device Model Number: D-1336-03-S
• Device Catalogue Number: D133603
• Device Lot Number: 17531106M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2016
• Initial Report FDA Received Date: 12/07/2016
• 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