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 09/30/2015

Event Type  Injury  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.The device history record (dhr) has been reviewed and it was verified that device was manufactured in accordance with documented specifications and procedures.Concomitant products during procedure: carto 3 (15025), stockert st-5509, coolflow pump hei06390, smarttouch catheter (cat#:d132704, lot#:17285310m), soundstar catheter (cat#:10438577, serial#:(b)(4)).(b)(4).Methods: no testing methods performed.Results: no results available since no evaluation performed.Conclusion codes: device discarded by user, unable to follow-up.(b)(4) the device was not returned to bwi.

Event Description

It was reported that a patient underwent an atrial fibrillation ablation procedure on (b)(6) 2015 using a pentaray nav catheter.The patient developed pericardial effusion which was noticed after the ablation where the patient had a slight drop in blood pressure.The patient suffered cardiac tamponade later in the night, and an intervention was performed to suture the area of the perforation in the superior vena cava (svc).The physician believes the event was caused by the spines of the pentaray catheter closing together and pinching patient tissue because of the way the long sheath (st.Jude lamp 45) locked the spines in place.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation ablation procedure using a pentaray nav catheter and suffered cardiac tamponade.The physician believed it occurred early in the procedure when there was difficulty advancing the pentaray catheter.He removed the pentaray and noticed tissue on the spines of the catheter, believing the issue became caught on the catheter as it was withdrawn through the tip of the sheath.Upon receipt, the catheter was visually inspected and it was found in normal conditions.No tissue or damages were observed on catheter spines.Per the event reported the catheter outer diameters were measured and it was found within specifications.No resistance was noticed while the catheter was introduced into an ifu recommended sheath.The catheter was evaluated for eeprom, and the functionality of the sensor catheter was tested 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.The device was tested for electrical performance and it was found within specifications.A deflection test was performed and the catheter passed.An irrigation test was performed and the catheter failed.Further examination revealed that the irrigation tubing was found bent at tip/shaft transition.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.Catheter failed during irrigation test however; the root cause of the tamponade remains unknown.The ifu states that careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade.A corrective action was created to address the pentaray nav occlusion/leak issues.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 10/15/2015.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.(b)(4).

• 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 ; 9497893837
• MDR Report Key: 5154588
• MDR Text Key: 28454735
• Report Number: 9673241-2015-00757
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: D-1282-07-S
• Device Catalogue Number: D128207
• Device Lot Number: 17230849L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention