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 Difficult to Remove (1528); Device Inoperable (1663); Component Missing (2306)

Patient Problem Physical Entrapment (2327)

Event Date 03/14/2016

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.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.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.(b)(4).

Event Description

It was reported that a (b)(6) female patient underwent an ablation procedure for atrial fibrillation with a pentaray nav eco high-density mapping catheter and suffered a medical device entrapment requiring surgical intervention.During mapping of the left atrium, one of the pentaray splines got entrapped in the artificial mechanical mitral valve.Physician was unable to withdraw the catheter without difficulty.When the physician was able to remove the catheter, one spline was missing.Entrapped pentaray spline led to valve dysfunction.The procedure was aborted.The patient was sent for surgical intervention for open heart cardiac surgery removal of the spline.Mitral valve function was restored via removal of detached pentaray spine.No valve replacement was necessary.Throughout the process, patient remained hemodynamically stable.Patient was reported to be in stable condition immediately after the event.Patient required extended hospitalization as a result of this adverse event.The patient has since fully recovered with no residual effects.The physician did not provide causality opinion.Patient medical history includes artificial mechanical mitral valve since 2006.The pentaray instructions for use states "use of this catheter may not be appropriate for use in patients with prosthetic valves.".

Manufacturer Narrative

It was reported that a (b)(6) female patient underwent an ablation procedure for atrial fibrillation with a pentaray nav eco high-density mapping catheter and suffered a medical device entrapment requiring surgical intervention.During mapping of the left atrium, one of the pentaray splines got entrapped in the artificial mechanical mitral valve.Physician was unable to withdraw the catheter without difficulty.When the physician was able to remove the catheter, one spline was missing.Entrapped pentaray spline led to valve dysfunction.The procedure was aborted.The patient was sent for surgical intervention for open heart cardiac surgery removal of the spline.Mitral valve function was restored via removal of detached pentaray spine.No valve replacement was necessary.Throughout the process, patient remained hemodynamically stable.Patient was reported to be in stable condition immediately after the event.Patient required extended hospitalization as a result of this adverse event.The patient has since fully recovered with no residual effects.The physician did not provide causality opinion.Patient medical history includes artificial mechanical mitral valve since 2006.The pentaray instructions for use states ¿use of this catheter may not be appropriate for use in patients with prosthetic valves.¿ the bwi failure analysis lab received the device for evaluation on 04/13/2016.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.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

(b)(4).It was reported that a (b)(6) female patient underwent an ablation procedure for atrial fibrillation with a pentaray nav eco high-density mapping catheter and suffered a medical device entrapment requiring surgical intervention.Upon receiving, the catheter was visually inspected and approximately 2cm of spine c was found detached from the catheter.Internal wires were found exposed.Per the information described in the event reported there was an artificial mechanical mitral valve implanted on the patient; this might have contributed to the spine detachment since the instructions for use indicates that the catheter may not be appropriate for use in patients with prosthetic valves.During the analysis, elongation marks were observed on the damaged spine; this condition might be related to the entrapment on the mechanical mitral valve.The catheter was evaluated for eeprom, carto 3 and sensor functionality.The catheter was recognized by carto 3 system, no error messages were displayed and the catheter was properly visualized, except for the detached spine.Eeprom data demonstrates the catheter was properly calibrated during manufacturing.The catheter was tested for electrical performance and it was found within specifications; however spine c was not available to be evaluated.A deflection test was performed and the catheter passed.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 customer complaint has been verified.Based on available analysis results, the catheter spine detachment was caused by an entrapment of the spine on the mechanical mitral valve implanted on the patient.An internal corrective action was opened to update the instructions for use wording on use of this device in prosthetic valves.

• 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: 5548339
• MDR Text Key: 41910799
• Report Number: 9673241-2016-00225
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: D-1282-08-S
• Device Catalogue Number: D128208
• Device Lot Number: 17333154L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2015
• 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; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 48