MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number D-1282-11-S

Device Problem Device Handling Problem (3265)

Patient Problems Cardiac Tamponade (2226); Injury (2348); Cardiac Perforation (2513)

Event Date 04/15/2016

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.Smartablate generator.Smartablate pump.Smarttouch catheter (model# d-1327-05-s, lot# 17372434m) (b)(4).

Event Description

It was reported that a (b)(6) male patient underwent an ablation procedure for persistent atrial fibrillation with a pentaray catheter and suffered a cardiac tamponade requiring pericardiocentesis and surgical intervention.During mapping, following ablation of the left pulmonary vein antra, the catheter was going outside of the image of the heart on the carto 3 system.Perforation was confirmed via contrast injection into the sheath.Pericardiocentesis was performed and yielded 400cc of fluid.The patient was stabilized and transferred to surgery to repair a small tear in the left atrial roof.The patient required extended hospitalization for 2-3 extra days to recover from open-chest surgery as a result of this adverse event.Patient outcome has improved.Patient recovered from surgery and was discharged home.There were no factors cited that may have contributed to the adverse event.The physician's opinion regarding the cause of the adverse event is that the left atrial roof was perforated by the st.Jude medical swartz sl2 8.5 french sheath and the pentaray catheter as a result of excessive pressure.It was noted that it was unclear how much of the pentaray was outside of the sheath at the time of perforation.A transseptal puncture was performed with a st.Jude medical brk needle.Sheath used was a st.Jude medical swartz sl2 8.5 french.Generator was set on 30 watts and was not titrated during ablation.Other generator settings were not reported as there was no ablation at the site of injury.Irrigated catheter flow was set at 17 ml/min.No error messages were observed on bwi equipment during the procedure.Patient received anticoagulant during the procedure with activated clotting times maintained at more than 350 seconds.

Manufacturer Narrative

(b)(4).It was reported that a (b)(6) male patient underwent an ablation procedure for persistent atrial fibrillation with a pentaray catheter and suffered a cardiac tamponade requiring pericardiocentesis and surgical intervention.The returned device was visually inspected and it was found in normal conditions.The catheter was tested for electrical performance 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 catheter sensor on carto system.The catheter was recognized by carto 3 system, no error messages were displayed and the catheter was properly visualized.Eeprom data demonstrates the catheter was properly calibrated during manufacturing.An irrigation test was performed and the catheter passed, no occlusion was observed.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: PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• 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: 5648549
• MDR Text Key: 45024158
• Report Number: 9673241-2016-00318
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• PMA/PMN Number: K123837
• 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: 04/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: D-1282-11-S
• Device Catalogue Number: D128211
• Device Lot Number: 17414232L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 55 YR