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

Model Number D-1266-01-S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Low Blood Pressure/ Hypotension (1914); Thrombosis (2100); Cardiac Tamponade (2226)

Event Date 02/04/2016

Event Type  Injury  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Since the lot number is unknown, the full udi number can not be provided.Concomitant products: lasso sas catheter, model #: d-1312-01-s.Webster 10 pole, model #: d-1079-230-s, lot #: unknown_d-1079-230-s.Carto 3 system, model #: m-4800-01.(b)(4) are related to the same incident.(b)(4).

Event Description

It was reported that a patient, underwent a pulmonary vein isolation procedure with an ez steer thermocool sf navigational catheter and a navistar rmt thermocool catheter and suffered a cardiac tamponade and thrombosis which required a pericardiocentesis and surgical intervention.The patient's medical history is unknown.Three and a half hours into the procedure, they were having difficulty accessing under the left inferior vein and getting the back wall contact.Therefore, they were not achieving vein isolation.They then switched to a manual catheter.When ablating around the right veins, blood pressure was noted to be decreasing.An echo was requested and some fluid around the heart border was seen.The procedure was aborted and a pig tail was inserted to drain the effusion and 960 ml of blood was removed from the pericardial space.The patient was also taken to the operation room to remove a clot from the pericardial space.There is no information about the hospitalization.The patient was reported to be in stable condition at the time the complaint was reported.The ablation settings varied depending on the location.The physician suggested that the cardiac tamponade was not due to any equipment problems or during ablation.He thought that it may have occurred while manipulating the catheter on the right hand side of the left atrium.This issue did not occur while ablating.He also mentioned that the transseptal puncture was quite right/anterior in orientation.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Therefore, we will report this event conservatively under both the ablation catheters used during the procedure as it was reported that the symptoms were noted during ablation.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 3/28/16.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(b)(4).

Manufacturer Narrative

Originally the lot number was reported as unknown.However, during the biosense webster failure analysis, the lot number was retrieved.The lot number is 17300164m.(b)(4).It was reported that a patient, underwent a pulmonary vein isolation procedure with an ez steer thermocool sf navigational catheter and a navistar rmt thermocool catheter and suffered a cardiac tamponade and thrombosis which required a pericardiocentesis and surgical intervention.Three and a half hours into the procedure, they were having difficulty accessing under the left inferior vein and getting the back wall contact.Therefore, they were not achieving vein isolation.They then switched to a manual catheter.When ablating around the right veins, blood pressure was noted to be decreasing.An echo was requested and some fluid around the heart border was seen.The procedure was aborted and a pig tail was inserted to drain the effusion and 960 ml of blood was removed from the pericardial space.The patient was also taken to the operation room to remove a clot from the pericardial space.There is no information about the hospitalization.The patient was reported to be in stable condition at the time the complaint was reported.The returned device was visually inspected and it was found in normal conditions.Per the event, the catheter was tested for electrical performance, temperature response and generator test and it was found within specifications.A deflection test was performed and the catheter passed.The catheter was evaluated for eeprom, and the functionality of the sensor catheter was tested on the carto 3 system.The catheter was recognized by the carto 3 system, no error messages were displayed and the catheter was properly visualized.The eeprom data demonstrates the catheter was properly calibrated during manufacturing.An irrigation test was performed and the catheter failed; occlusion and leakage were observed.Further examination showed that the irrigation tubing was broken at the handle area as well as crystals were observed inside the tubing.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 failed during irrigation test; however this condition is not related to the cardiac tamponade reported.The root cause of the cardiac tamponade and patient consequences remains unknown.The instructions for use (ifu) states that careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade.Based on the available analysis finding results, the failure mode observed on the irrigation tubing does not appear to be caused by any internal biosense webster, inc.Processes.

• Brand Name: NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER
• 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: joaquin kurz ; 9497893837
• MDR Report Key: 5478015
• MDR Text Key: 39641979
• Report Number: 2029046-2016-00023
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: D-1266-01-S
• Device Catalogue Number: NR7TCSIY
• Device Lot Number: UNKNOWN_D-1266-01-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/05/2016
• Initial Date FDA Received: 03/03/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/05/2016; 04/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention