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

Model Number D-1197-16-S

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 04/14/2014

Event Type  Injury  

Event Description

During an atrial fibrillation procedure, it was reported that the patient developed a pericardial effusion.There was no indication for the cause of it.The patient remained stable and evaluated with an ultrasound to determine if a pericardiocentesis was required.On (b)(6), received additional information requested from bwi representative stating that the patient became hypotensive and the ice revealed a small-moderate pericardial effusion.Catheters were withdrawn to right side, heparin reversed and fluids given.Arterial line started and transthoracic echocardiogram (tte) done.Blood pressure was stabilized in the 80's and eventually tapped for 1100 cc and remained intubated the following day.The patient did not require further intervention.The outcome of the patient was an improved.The physician¿s opinion regarding the causality of this event was possible procedure related.

Manufacturer Narrative

The device has been disposed by the customer.As the lot # 16010383m was provided, 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) concomitant bwi products: product: soundstar 3d diagnostic ultrasound catheter: us catalog # sndstr10, lot # 10864835000039.Product: lasso nav eco variable catheter: us catalog # d134301, lot # 15900077l.Product: carto 3 system: us catalog # fg540000, serial # (b)(4).Product: stockert 70 rf generator: us catalog # s7001, serial # (b)(4).Product: coolflow irrigation pump: us catalog # cfp002, 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. (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: 3777951
• MDR Text Key: 4434729
• Report Number: 9673241-2014-00161
• 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: 04/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2014
• 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 JRZ
• 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): Hospitalization; Life Threatening