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

Model Number D-1282-10-S

Device Problems Break (1069); Entrapment of Device (1212); Material Rupture (1546); Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 12/12/2016

Event Type  Injury  

Manufacturer Narrative

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.Concomitant products: carto 3 system, model # m-4800-01, s/n: (b)(4); smartablate generator, model # m-4900-07, s/n: (b)(4); smartablate pump, model # m-4900-08, s/n: (b)(4); webster cs catheter, model # d-1353-04-s, lot # 17603160m; soundstar eco catheter, model # m-5723-16, s/n: unknown; smart touch catheter, model number unknown, lot # 17489878l.(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 catheter where the catheter became lodged in her mitral valve, causing a rupture.Upon retraction, one of the catheter splines broke off and became stuck in the leaflet of the valve.This was confirmed by both transesophageal echocardiogram (tee) and fluoroscopy.The patient was taken for left heart catheterization and evaluation, but extraction surgery was scheduled for a later time.He patient remained in the hospital in stable condition while extraction surgery was planned.N the day of extraction, the spline could no longer be visualized by tee.Using fluoroscopy, it was found in the lower extremity of the valve, and was removed with an intervascular snare.The patient¿s mitral valve is mechanical.Multiple attempts have been made to obtain clarification to this complaint, but no further information has been made available.

• 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: 6230504
• MDR Text Key: 64135613
• Report Number: 9673241-2017-00006
• 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: 12/12/2016

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: 08/31/2019
• Device Model Number: D-1282-10-S
• Device Catalogue Number: D128210
• Device Lot Number: 17564900L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/12/2016
• Initial Date FDA Received: 01/06/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/09/2016
• 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: 71 YR