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

Model Number D-1197-17-S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pseudoaneurysm (2605)

Event Date 08/04/2014

Event Type  Injury  

Event Description

This event was part of (b)(6).The ablation catheter used was the navistar thermocool.It was reported that after the procedure, the patient had vascular pseudoaneurism (psa).No additional medical/surgical intervention nor prolong hospitalization were required.The patient fully recovered.No claim of product malfunction.The physician¿s opinion regarding the cause of this adverse event is that it was procedure related.Psa is one of the most common vascular complications of cardiac and peripheral angiographic procedures.The most possible catastrophic complication of psa is rupture.Therefore this serious adverse event is determined to be mdr reportable.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.The device history record (dhr) was reviewed.The dhr review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).Concomitant product: lasso variable catheter, model #: d-1237-02-s, lot #: 15944566l, quantity 2.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

In the 3500a report submitted on october 22, 2014, it was stated that the reported concomitant product of lasso variable catheter was a quantity involved of 2.After, a correction was received on october 22, 2014 stating that the quantity involved was 1.(b)(4).

Manufacturer Narrative

On 12/1/2014, biosense webster received confirmation that stated this event did not require any medical/surgical intervention nor prolong hospitalization.Also there was no life- threatening to the patient of this event.Therefore this event was not mdr reportable.(b)(4).

• Brand Name: NAVISTAR® THERMOCOOL® 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: 4194793
• MDR Text Key: 5152390
• Report Number: 9673241-2014-00436
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: D-1197-17-S
• Device Catalogue Number: NI75TCFH
• Device Lot Number: 15919232M
• Other Device ID Number: (01)10846835000566
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening