MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) NAVISTAR® THERMOCOOL®; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number D-1197-16-S

Device Problem Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.Manufacturer ref # (b)(4).

Event Description

It was reported, during a procedure the customer noticed that the catheter package (pouch seal) was defected.This issue is indicative of a reportable event since the sterility of the product was compromised.The case was completed by changing the catheter without any patient consequences.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation.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.

Manufacturer Narrative

(b)(4).It was reported, during a procedure the customer noticed that the catheter package was defected.This issue is indicative of a reportable event since the sterility of the product was compromised.The case was completed by changing the catheter without any patient consequences.Additionally a picture was received with the compliant.On the image it was observed a pouch with a hole on the back part of it.Quality control process was review and it was documented that during manufacturing 3 steps of inspections are performed to 100% of the lot devices.During the first step a visual and tactual inspection to the shaft is performed.Then a second inspection is performed to the usable length of the product.And the 3rd step is a general visual inspection on the catheter.According to the investigation and limited to the information in the event description section and the picture provided by the affiliate, the packaging team concluded that the defect was not related to the packaging process.The device history record (dhr) was reviewed and no anomalies were found.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Customer complaint cannot be confirmed.

• Brand Name: NAVISTAR® THERMOCOOL®
• 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 32599 ; MX 32599
• Manufacturer Contact: shahe garabedian ; 9098397362
• MDR Report Key: 4962616
• MDR Text Key: 24655094
• Report Number: 9673241-2015-00499
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 07/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2018
• Device Model Number: D-1197-16-S
• Device Catalogue Number: NI75TCDH
• Device Lot Number: 17212809M
• Other Device ID Number: (01)10846835000559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2015
• 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