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)

Event Date 01/26/2017

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.Concomitant products: carto 3 rmt system, model # m-5830-01, s/n: (b)(4).Stockert generator, model # m-5463-01, s/n: (b)(4).Coolflow pump, model # m-5491-02, s/n: (b)(4).Soundstar eco catheter, model # m-5723-17, s/n: (b)(4).Pentaray nav eco catheter, model # d-1282-11-s, lot # 17615598l.Webster 4 pole catheter, model # d-1079-236-s, lot # 17615267m.Baylis medical transseptal needle.St.Jude medical sl1 8.5fr sheath.(b)(4).

Event Description

It was reported that a (b)(6) female patient underwent an ablation procedure for atrial fibrillation with a navistar rmt thermocool catheter and suffered a cardiac tamponade requiring pericardiocentesis and anticoagulant reversal.During ablation phase, the patient became hypotensive and a tamponade was detected.Anticoagulant was reversed.Pericardiocentesis yielded an unspecified amount of fluid.Patient was reported to be in stable condition at the end of the procedure.Patient will be transferred to the coronary care unit for observation.Patient remained in the hospital overnight.There is no information regarding if hospitalization was extended beyond the expected length of stay.Factors cited that may have contributed to the adverse event include a possible association with a tissue disorder (unspecified).Physician¿s opinion regarding the cause of the adverse event is that it was procedure-related, specifically, excessive radiofrequency power delivery.Transseptal puncture was performed with a baylis medical transseptal needle.Sheath in use was a st.Jude medical sl1 8.5 french.Generator parameters at the time of injury included power control mode at 50 watts with temperature cut-off of 50 degrees celsius.Generator settings at the time of injury included power at 50 watts (not titrated), average temperature of 33 degrees celsius, and average impedance of 100 ohms.Overall ablation time at the site of injury was 33 seconds.Last ablation cycle time at the site of injury was 33 seconds.Irrigated catheter flow was set at 30 ml/min.Patient received anticoagulant during the procedure with activated clotting time maintained between 250-300 seconds.There were no errors reported on any bwi equipment during the procedure.

Manufacturer Narrative

(b)(4).It was reported that a (b)(6) female patient underwent an ablation procedure for atrial fibrillation with a navistar rmt thermocool catheter and suffered a cardiac tamponade requiring pericardiocentesis and anticoagulant reversal.The returned device was visually inspected, and was found in good condition.The catheter was tested for electrical performance, temperature response and generator compatibility, and it was found within specifications.A deflection test was performed, which the catheter passed.The catheter was then evaluated for eeprom, carto 3 system performance and sensor functionality.The catheter was recognized by the carto 3 system with no error messages and proper visualization.Eeprom data demonstrates that the catheter was properly calibrated during manufacturing.Finally, an irrigation test was performed, which the catheter passed.However, during the test, leakage was observed at the luer hub area.Further investigation revealed that there were some bubbles/breakage near the polyurethane.An investigation was performed along with the manufacturing team, but the failure could not be replicated during the manufacturing process.Current manufacturing process controls assure the quality and integrity of the catheter as it pertains to luer hub leakage.It is possible that the catheter was handled inappropriately, perhaps connection to the coolflow pump tubing.Awareness training was performed for the manufacturing process associates in order to avoid future failures of this type.The device history record (dhr) was reviewed, and no anomalies were found.The dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The customer complaint regarding the cardiac tamponade was not confirmed.The root cause of the luer hub damage could be related to the handling and manipulation of the catheter during the procedure.The luer hub issue is not related to the cardiac tamponade, the root cause of which remains unknown.The instructions for use state 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 ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6348095
• MDR Text Key: 67937220
• Report Number: 9673241-2017-00137
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835008500
• UDI-Public: (01)10846835008500(11)161022(17)190930(10)17597239M
• 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: 01/26/2017

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: 09/30/2019
• Device Model Number: D-1266-01-S
• Device Catalogue Number: NR7TCSIY
• Device Lot Number: 17597239M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/26/2017
• Initial Date FDA Received: 02/21/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2016
• 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
• Patient Age: 77 YR