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

Model Number D-1266-01-S

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 09/22/2015

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.Concomitant products: carto 3 system (model# m-4800-01, (b)(4)); stockert 70 system (model# m-5463-01, (b)(4)); coolflow pump (model# m-5491-02, (b)(4)).(b)(4).

Event Description

It was reported that a male patient underwent an atrial fibrillation procedure with a navistar® rmt thermocool® electrophysiology catheter and suffered a cardiac tamponade, which required blood plasma, medications, pericardiocentesis and surgery.It is reported that after a transseptal puncture with a st.Jude medical brk needle and ablations were performed the patient's blood pressure dropped.A pericardial effusion was noted on ultrasound and a pericardiocentesis was performed in which 500cc of fluid was withdrawn, in addition, blood plasma and medications were given.The patient was under general sedation.There were no error messages observed on biosense webster equipment during the procedure and no equipment issues, as everything was working within specifications.Additional information was received on the event.The patient received anticoagulation during the procedure which was maintained at 300-350s.The event most likely occurred during the ablation phase, as when the radiofrequency applications were being applied a drop in the patient's blood pressure was noticed.Open heart surgery was required to plug the bleeding.The patient did require hospitalization due to open heart surgery.The patient was reported to be recovering at the time bwi followed-up with the physician.The overall ablation time at the site of injury was 30 seconds.Settings during the event include: power settings 50 watts / impedance 120 ohms / irrigation flow setting 30 ml/min / 8.5f agilis sheath used.The power was not titrated during ablation.The physician did not provide a causality opinion for the cause of this adverse event.However, the physician does not think product malfunction was a factor.

Manufacturer Narrative

(b)(4).It was reported that a male patient underwent an atrial fibrillation procedure with a navistar® rmt thermocool® electrophysiology catheter and suffered a cardiac tamponade, which required blood plasma, medications, pericardiocentesis and surgery.The returned device was visually inspected upon receipt and it was found in normal conditions.Per the event, an irrigation test was performed and the catheter passed, no occlusion was observed.A deflection test was performed and the catheter passed.The catheter was also evaluated for carto 3.The catheter was recognized by carto 3 system, no error messages were displayed and the catheter was properly visualized.The catheter was tested for electrical performance, temperature response and stockert compatibility and it was found within specifications.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 tamponade remains unknown.The instructions for use states that careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade.

• 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. (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 ; 9497893837
• MDR Report Key: 5145855
• MDR Text Key: 28108495
• Report Number: 9673241-2015-00728
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• 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: Followup
• Report Date: 09/22/2015

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: 06/30/2018
• Device Model Number: D-1266-01-S
• Device Catalogue Number: NR7TCSIY
• Device Lot Number: 17248290M
• Other Device ID Number: SEE H10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2015
• 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): Hospitalization; Life Threatening; Required Intervention