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 Improper or Incorrect Procedure or Method (2017)

Patient Problem Hematoma (1884)

Event Date 01/28/2015

Event Type  Injury  

Event Description

It was reported that a female, (b)(6) patient taking part in the (b)(4) study suffered a moderate hematoma related to vascular access complication during an ablation procedure.The principal investigator classified the event as not device related and definitely procedure related.The patient did not require intervention to prevent permanent damage; however hospitalization was prolonged for 3 days.Further detail for the reason of prolonged hospitalization has been requested, however no additional information has been provided yet.A supplemental report will be submitted once bwi receives any additional information.

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.(b)(4).

Manufacturer Narrative

Upon following up with the customer, bwi received additional information on march 20th 2015 which is stated that the patient did not required any medical intervention, however the reason of prolonged hospitalization was for observation due to hemoglobin reduced from 14g/dl to 9g/dl.(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 hwy; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 4583103
• MDR Text Key: 16458588
• Report Number: 9673241-2015-00136
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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
• Report Date: 02/18/2015

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: 05/31/2017
• Device Model Number: D-1197-17-S
• Device Catalogue Number: NI75TCFH
• Device Lot Number: 17016503M
• 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
• Initial Date Manufacturer Received: 02/17/2015
• Initial Date FDA Received: 03/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/08/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/08/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 79 YR