MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC (IRWINDALE) NAVISTAR® THERMOCOOL®; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number D-1197-16-S

Device Problem Unintended Movement (3026)

Patient Problems Death (1802); Perforation (2001); Cardiac Tamponade (2226)

Event Date 02/18/2013

Event Type  Death  

Event Description

During a procedure, it was reported that a perforation on the right atrium was noticed during ablation with 40 watts.A pulmonary vein isolation (pvi) was performed and then a wolff-parkinson-white (wpw) when the perforation was noted.The event outcome: patient deceased.On (b)(4), received additional information requested from bwi representative stating that a cardiac tamponade was observed, cardiopulmonary resuscitation (cpr) and pericardial drainage was performed.The patient required hospitalization.The physician's opinion regarding the causality of this event was procedure related.

Manufacturer Narrative

The device has been disposed by the customer.Since no lot number was provided, no device history record review could be performed.Concomitant bwi products: product: carto xp system; us catalog # fg-4700-00; serial # unknown.Product: stockert ep-shuttle radio frequency generator: us catalog # 39d-76x; serial # (b)(4).Product: coolflow irrigation pump: us catalog # cfp001, serial # (b)(4).

• Brand Name: NAVISTAR® THERMOCOOL®
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 3792830
• MDR Text Key: 4530171
• Report Number: 2029046-2014-00138
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-1197-16-S
• Device Catalogue Number: NI75TCDH
• Device Lot Number: UNKNOWN_D-1197-16-S IRW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Weight: 90