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

Model Number D-1282-07-S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation (2001); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 09/24/2014

Event Type  Injury  

Event Description

It was reported that a female patient underwent an atrial fibrillation (afib) procedure with a pentaray navigational eco catheter and suffered a cardiac tamponade which required a pericardiocentesis.The patient¿s medical history is unknown.It was reported that the patient experienced a pericardial effusion.After the second transseptal puncture, the ablation catheter was placed in the left superior vein and the pentaray navigational eco catheter was used to start the fast anatomical mapping (fam) in the roof of the left atrium (la).After, the pressure drop was noted.The intracardiac echocardiogram catheter was used to identify the pericardial effusion.The procedure was aborted and a pericardiocentesis was performed.The patient was stable at this time.Additional information was received regarding the event.During the mapping phase, the physician was using pentaray navigational eco catheter for the first time and felt that he perforated the left atrial appendage with the pentaray navigational eco catheter causing a cardiac perforation.There were two transseptal punctures performed using a st.Jude agilis nxt sheath and 98cm brk-xs transseptal needle.The patient had just received heparin and the act was greater than 350s at the time of the perforation.Protamine was given immediately and the pericardiocentesis was performed with transthoracic echocardiogram and fluoroscopy guidance.The patient did require hospitalization.No ablation was performed.There were no error messages observed on biosense webster equipment during the procedure.The st.Jude sl 0 63cm sheath was used during the procedure.

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, serial # (b)(4)), stockert 70 (model # m-5463-01, serial # (b)(4)), coolflow pump (model # m-5491-02, serial # (b)(4)), acunav catheter (model # unknown, serial # unknown), webster decapolar catheter (model # d-1086-586-s, lot # 170501173m), smart touch catheter (model # d-1327-05-s, lot # 17039201m).(b)(4).

Manufacturer Narrative

(b)(4) it was reported that a female patient underwent an atrial fibrillation (afib) procedure with a pentaray navigational eco catheter and suffered a cardiac tamponade which required a pericardiocentesis.The patient¿s medical history is unknown.It was reported that the patient experienced a pericardial effusion.After the second transseptal puncture, the ablation catheter was placed in the left superior vein and the pentaray navigational eco catheter was used to start the fast anatomical mapping (fam) in the roof of the left atrium (la).After, the pressure drop was noted.The intracardiac echocardiogram catheter was used to identify the pericardial effusion.The procedure was aborted and a pericardiocentesis was performed.The patient was stable at this time.The returned device was visually inspected upon receipt and it was found in normal conditions.Per the event, the catheter was tested for electrical performance, temperature response and stockert compatibility and it was found within specifications.Furthermore, an irrigation test was performed and the catheter passed, no occlusion was observed.Then, the catheter was evaluated for eeprom, carto 3 and coil disconnection tester (cdt).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.Finally, the sensor coils resistances were found within specifications.Finally, a deflection test was performed and the catheter passed.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 pericardial effusion remains unknown.The ifu 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 3259 9; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 3259 9; MX 32599
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 4197875
• MDR Text Key: 4966628
• Report Number: 9673241-2014-00441
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: D-1282-07-S
• Device Catalogue Number: D128207
• Device Lot Number: 17056668L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2014
• 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