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 Problems Entrapment of Device (1212); Labelling, Instructions for Use or Training Problem (1318)

Patient Problem No Information (3190)

Event Date 04/08/2016

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.(b)(4).The device was not returned to bwi.

Event Description

It was reported that a (b)(6) female patient underwent an ablation procedure for atrial fibrillation with a pentaray nav eco 7 french catheter and suffered a medical device entrapment requiring surgical intervention.The pentaray spine with electrodes 17-18 and 19-20 got entrapped in the mechanical mitral valve.The septal fin became stuck in the closed position.The spine of the catheter was removed from the mechanical mitral valve via femoral vein access using a deflectable sheath and a lasso-type catheter.The femoral vein access which was established during the carto case for atrial fibrillation ablation was removed at the end of the case.A new access was used 3 days later to retrieve the pentaray spine.Upon removal of the pentaray spine, mechanical valve function was restored.Patient was fully recovered with no residual effects.On april 14, 2016, biosense webster inc.Initiated a voluntary labeling correction to clarify an existing contraindication relative to patients with prosthetic valves in the instructions for use (ifu) for all pentaray catheters.The current language in the ifu provides a precaution against use of the pentaray catheter in patients with prosthetic valves under the contraindication section stating: "[the] use of this catheter may not be appropriate for use in patients with prosthetic valves." we are updating the ifu to clarify the contraindication statement as follows: "do not use pentaray catheters in patients with prosthetic valves".

Manufacturer Narrative

The device history record (dhr) for the lot number 17428250l has been reviewed and it was verified that device was manufactured in accordance with documented specifications and procedures.

• 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: 5618500
• MDR Text Key: 44009931
• Report Number: 9673241-2016-00303
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2016
• 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-1282-08-S
• Device Catalogue Number: D128208
• Device Lot Number: 17428250L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/27/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 59 YR