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

Model Number D-1282-11-S

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/26/2016

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 patient, (b)(6), male, underwent an atrial tachycardia procedure with a pentaray nav eco high-density mapping catheter and an electrode and tip became detached inside of the patient.The patient has a prosthetic tricuspid valve and a prosthetic mitral valve.After geometry was created around the tricuspid annulus by the ablation catheter, the physician mapped with the pentaray catheter.During the mapping, the c spline of the pentaray was entrapped to the prosthetic tricuspid valve.The physician withdrew the pentaray with care, but electrode 11 and its distal portion was detached and separated and the separated tip remained in the patient body.The procedure ended without further intervention.After the procedure, it was confirmed that the separated tip was within the peripheral right lower pulmonary artery.The patient was monitored in the intensive care unit.In the contraindication section of the instruction for use for this device it states "use of this catheter may not be appropriate for use in patients with prosthetic valves.".

Manufacturer Narrative

Correction, this is a female patient.It was previously reported in initial report that it was a male patient.Sex was originally reported correctly as female.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

It was reported that a patient, (b)(6), male, underwent an atrial tachycardia procedure with a pentaray nav eco high-density mapping catheter and an electrode and tip became detached inside of the patient.The patient has a prosthetic tricuspid valve and a prosthetic mitral valve.After geometry was created around the tricuspid annulus by the ablation catheter, the physician mapped with the pentaray catheter.During the mapping, the c spline of the pentaray was entrapped to the prosthetic tricuspid valve.The physician withdrew the pentaray with care, but electrode 11 and its distal portion was detached and separated and the separated tip remained in the patient body.The procedure ended without further intervention.After the procedure, it was confirmed that the separated tip was within the peripheral right lower pulmonary artery.The patient was monitored in the intensive care unit.In the contraindication section of the instruction for use for this device it states ¿use of this catheter may not be appropriate for use in patients with prosthetic valves.¿ the product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.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".

• 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: 5451460
• MDR Text Key: 38710196
• Report Number: 9673241-2016-00109
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2018
• Device Model Number: D-1282-11-S
• Device Catalogue Number: D128211
• Device Lot Number: 17210016L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/17/2015
• 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
• Patient Age: 41 YR