MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number D-1197-16-S

Device Problems Charred (1086); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2014

Event Type  malfunction  

Event Description

During an idiopathic ventricular tachycardia procedure, it was reported that the navi-star¿ thermo-cool¿ electrophysiology catheter stopped deflecting when attempting to deflect it.The catheter was replaced with a same like product.The procedure was continued and completed successfully with no patient consequences.On (b)(6), our failure analysis lab found char on the proximal end of the tip dome from the product returned, measuring more than 1 mm in length.Based on this finding, it was determined for this complaint to be reportable due to the potential risk for the patient.Awareness date changed from (b)(6).

Manufacturer Narrative

The device investigation is still in progress.(b)(4).

Manufacturer Narrative

(b)(4) during an idiopathic ventricular tachycardia procedure, it was reported that the navi-star thermo-cool electrophysiology catheter stopped deflecting when attempting to deflect it.The catheter was replaced with a same like product.The procedure was continued and completed successfully with no patient consequences.On april 15th, our failure analysis lab found char on the proximal end of the tip dome from the product returned, measuring more than 1 mm in length.Upon receiving, the catheter was visually inspected and char was found on the tip electrode.This condition was not reported by the customer.Per the complaint, the catheter was tested for deflection and failed.Afterwards, the catheter was dissected and the puller wire was found broken inside the handle, causing the deflection issue.Due to the char found, the catheter was tested for electrical performance, temperature response and stockert compatibility and found within specifications.In addition, an irrigation test was performed and catheter passed.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 was confirmed.For the char found, it remains unknown the origin of it.

• Brand Name: NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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 3259 9; MX 32599
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 3777501
• MDR Text Key: 21314358
• Report Number: 9673241-2014-00159
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: D-1197-16-S
• Device Catalogue Number: NI75TCDH
• Device Lot Number: 16039456M
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1