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

Model Number	D-1313-05-S
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	01/11/2014
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) for the lot number 15950983l has been reviewed and it was verified that device was manufactured in accordance with documented specifications and procedures.(b)(4).
Event or Problem Description
It was reported that a (b)(6) male patient underwent a pulmonary vein isolation ablation procedure for symptomatic persistent atrial fibrillation with an ez steer thermocool sf navigational catheter and suffered a pericardial effusion requiring extended hospitalization.On the day of the procedure, a pericardial effusion was observed.The patient required extended hospitalization as a result of this adverse event.The issue resolved without sequelae.Medical history includes hypertension, ascending aorta mild dilatation, atrial flutter, and sinus bradycardia.Principal investigator assessed this event to be mild in severity, serious, possibly device-related, and definitely procedure-related.Since the patient required extended hospitalization as a result of this event, it is mdr reportable.

• Brand Name: THERMOCOOL® SF NAV BI-DIRECTIONAL 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: 6024452
• Report Number: 9673241-2016-00692
• Device Sequence Number: 1838005
• Product Code: LPB
• UDI-Device Identifier: 10846835003208
• UDI-Public: (01)10846835003208(11)130911(17)160831(10)15950983L
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 01/16/2014

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: 08/31/2016
• Device Model Number: D-1313-05-S
• Device Catalogue Number: BNI35DFCT
• Device Lot Number: 15950983L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2014
• Initial Report FDA Received Date: 10/12/2016
• 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: Hospitalization
• Patient Age: 76 YR