MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ); CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number GENERIC - EZ STEER NAV (TC)

Device Problem Insufficient Information (3190)

Patient Problems Dyspnea (1816); Nerve Damage (1979)

Event Date 08/06/2013

Event Type  Injury  

Event Description

It was reported to a bwi representative that during patient¿s follow up visit (unknown date) who had an atrial fibrillation case on (b)(6) 2013, the patient experienced shortness in breath and the physician diagnosed it as unilateral phrenic nerve damage.The patient did not required hospitalization and was stable.On (b)(6), received additional information requested from bwi representative stating that the patient outcome from this event was unchanged.The physician¿s opinion regarding the causality of this adverse 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 3 system; us catalog # fg540000; serial # (b)(4).Product: stockert 70 rf generator; us catalog # s7001; serial # unknown.Product: coolflow irrigation pump; us catalog # cfp002; serial # unknown.(b)(4).

• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 3259 9; MX 32599
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 3792880
• MDR Text Key: 4479170
• Report Number: 9673241-2014-00178
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2014

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: GENERIC - EZ STEER NAV (TC)
• Device Lot Number: UNKNOWN_D-1292-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/15/2014
• 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): Life Threatening