MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) CELSIUS¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number D-1189-03-S

Device Problem Insufficient Information (3190)

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation (2001); Loss of consciousness (2418); Pericardial Effusion (3271)

Event Date 04/24/2014

Event Type  Injury  

Event Description

It was reported that during an atrial fibrillation (afib) procedure, the catheter was placed in the left atrial appendage for pacing maneuvers and shortly after a drop in blood pressure was noted by staff with loss of consciousness.The patient developed a pericardial effusion.The physician felt that the left atrial appendage was perforated.A pericardiocentesis was performed.And approximately 2 liters was removed from the pericardial space.After reversing the blood thinners and giving the patient blood transfusions, the patient was transferred to surgery for surgical repair.

Manufacturer Narrative

Bwi products in use were: stockert: serial# (b)(4); cool flow pump: serial # (b)(4).(b)(4).

Manufacturer Narrative

(b)(4) it was reported that during an afib procedure, the patient developed a pericardial effusion.A pericardiocentesis was performed and approximately 2 liters were removed from the pericardial space.After reversing the blood thinners and giving the patient blood transfusions, the patient was transferred to surgery for surgical repair.The returned device was visually inspected upon receipt and it was found in normal conditions.Per the event, the catheter was tested for electrical performance, temperature response and stockert compatibility and it was found within specifications.Furthermore, an irrigation test was performed and the catheter passed, no occlusion was observed.Finally, a deflection test was performed and the catheter passed.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.The catheter passed all specifications.The root cause of the pericardial effusion remains unknown.The ifu states that careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade.

• Brand Name: CELSIUS¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER
• 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: 3793362
• MDR Text Key: 4371608
• Report Number: 9673241-2014-00182
• 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,Followup
• Report Date: 04/24/2014

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 Expiration Date: 12/31/2016
• Device Model Number: D-1189-03-S
• Device Catalogue Number: DI7TCFLRT
• Device Lot Number: 16032176M
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2014
• 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; Required Intervention