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

Model Number D-1282-08-S

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

Patient Problems Pulmonary Embolism (1498); Thrombosis (2100)

Event Date 11/23/2016

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) for the lot number 17534578l has been reviewed and it was verified that device was manufactured in accordance with documented specifications and procedures.Concomitant products: carto 3 system, model #:m-4800-01, serial #: (b)(4).Smartablate pump.Soundstar catheter.Biosense webster, inc.Bidirectional coronary sinus catheter.(b)(4) are related to the same incident.(b)(4).

Event Description

This event was originally reported under the thermocool smarttouch bi-directional navigation catheter.However, additional information was received stating that the thrombus was visualized on the pentaray navigational eco catheter.Therefore, we are also conservatively reporting this event under the pentaray navigational eco catheter.It was reported that a patient underwent an ablation procedure for left atrial tachycardia with a thermocool smarttouch bi-directional navigation catheter and a pentaray navigational eco catheter suffered an intraprocedural thrombosis (requiring heparin and attempted extraction) and post-procedural bilateral pulmonary embolisms (requiring an unspecified medication).Physician did not provide a causality opinion.During the procedure, a thrombus was visualized on the pentaray catheter via intracardiac echocardiogram (ice).Heparin was administered.Physician attempted to extract the thrombus.Patient was reported to be in a stable condition.Immediately post-procedure, the patient exhibited no neurological symptoms.Two weeks post-procedure, the patient returned to the hospital and was diagnosed with bilateral pulmonary embolisms.An unspecified medication was administered.Patient was recovering at the time of complaint update.Generator settings included temperature cut-off of 42 degrees celsius.No ablation was performed prior to visualizing the thrombus.Patient received anticoagulant (heparinized saline 500 units in 500 cc) during the procedure.It was noted that the ablation catheter did not fail.There were no catheter issues related to temperature or flow.There were no error messages reported on any biosense webster, inc.Equipment during the procedure.Since this adverse event required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.

• 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: 6345740
• MDR Text Key: 67851198
• Report Number: 9673241-2017-00131
• 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
• Report Date: 11/23/2016

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: 08/02/2016
• Device Model Number: D-1282-08-S
• Device Catalogue Number: D128208
• Device Lot Number: 17534578L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/23/2016
• Initial Date FDA Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/31/2019
• 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