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

Model Number D-1197-17-S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 02/23/2017

Event Type  Injury  

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Concomitant products: carto 3 system, model #: m-4800-01, serial #: (b)(4).Smartablate pump, model #: m-4900-08, serial #: (b)(4).Lasso navigational eco catheter, model #: d-1343-01-s, lot #: 17597636l.Preface sheath, model #: 301803ms.Non biosense webster, inc.- stryker bard coronary sinus catheter.Non biosense webster, inc.- stryker soundstar catheter 10 french.Non biosense webster, inc.- st.Jude medical brk1 transseptal needle 407201/5793266.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for left atrial flutter with a navistar thermocool catheter and suffered a cardiac tamponade requiring pericardiocentesis.During the procedure, the patient became hypotensive and a tamponade was confirmed via echocardiogram.Pericardiocentesis yielded 500 cc.Patient was reported to be in a stable condition.There is no information about the hospitalization.The physician did not provide a causality opinion for the cause of this adverse event.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Since this adverse event required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an ablation procedure for left atrial flutter with a navistar thermocool catheter and suffered a cardiac tamponade requiring pericardiocentesis.During the procedure, the patient became hypotensive and a tamponade was confirmed via echocardiogram.Pericardiocentesis yielded 500cc.Patient was reported to be in a stable condition.There is no information about the hospitalization.The physician did not provide a causality opinion for the cause of this adverse event.The returned device was visually inspected and it was found was in normal conditions.Per the event, the catheter was tested for electrical performance, temperature response and generator test and it was found within specifications.After that, deflection test was performed and the catheter passed.Then, an irrigation test was performed and the catheter passed, no occlusion was observed.Finally, the eeprom was intended to be read, however since the eeprom data showed no values, it can be determined the eeprom was corrupted.However, during the manufacturing process, all pieces are tested and inspected in order to prevent this type of defect before to leave the facility.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 customer complaint has not been verified.However, the root cause of the corrupted eeprom remains unknown.The eeprom failure is not related with the cardiac tamponade reported in the procedure; due to this the root cause of the cardiac tamponade remains unknown.

• Brand Name: NAVISTAR® THERMOCOOL® 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 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6423246
• MDR Text Key: 70539069
• Report Number: 9673241-2017-00226
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835000566
• UDI-Public: (01)10846835000566(11)161130(17)191130(10)17617640M
• 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: 02/23/2017

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: 11/30/2019
• Device Model Number: D-1197-17-S
• Device Catalogue Number: NI75TCFH
• Device Lot Number: 17617640M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/23/2017
• Initial Date FDA Received: 03/21/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2016
• 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