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

Model Number D-1266-01-S

Device Problems Impedance Problem (2950); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2015

Event Type  malfunction  

Event Description

It was reported that a patient underwent a right sided atrial tachycardia procedure with a navistar thermocool catheter when no impedance and no temperature issue occurred.There were no impedance or temperature readings on the stockert generator when the rmt thermocool catheter was connected to the piu.Changing out the catheter cable, redel cable and rebooting the generator did not resolve the issue.The catheter was then replaced and the issue was resolved.The procedure was then continued.There was no patient consequence.This event was originally assessed as not reportable as the ablation cannot be performed when there is no temperature or impedance.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The device was returned for analysis and the biosense webster failure analysis lab discovered the tip dome has some light brown and reddish brown material on it.The material came off of the tip dome during analysis.One piece measured width 0.757mm and length of about 0.297mm.Another piece has width measuring 1.552mm and length measuring 0.899mm.A scanning electron microscope (sem) analysis showed the material found was related to biological material.Upon request additional information was received on the returned catheter condition.This finding was not noticed when the catheter was removed from the field or packaged up.The bwi representative believes some blood may have still been in the catheter when it was packaged.This finding is indicative of a reportable event because the material easily came off therefore if this material would have dislodged inside of the patient, it could cause a serious injury.The awareness date for this record is (b)(6) 2015 because that is when the finding was discovered.

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.(b)(4).

Manufacturer Narrative

A kastle-meyer analysis was done which showed the material found was related to biological material.(b)(4).

Manufacturer Narrative

(b)(4) it was reported that a patient underwent a right sided atrial tachycardia procedure with a navistar thermocool catheter when no impedance and no temperature issue occurred.The returned device was visually inspected upon receipt and it was found a type of light brown and reddish brown foreign material at catheter dome.This event was reported to the fda because the material easily came off, therefore if this material would have dislodged inside of the patient, it could cause a serious injury.Analytic analysis was done to determine composition of the foreign material.Based on the analysis, it can be concluded that the particles found in the dome are related to biological material.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 returned device was then evaluated for electrical resistance and the thermocouple test passed.Then per the reported event, an irrigation test was performed and the catheter failed.The irrigation tube was found folded inside the handle, however it is unknown how the irrigation tube was damage since during manufactured process the catheters are 100% inspected for irrigation characteristics.The customer complaint cannot be confirmed.

• Brand Name: NAVISTAR® RMT 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: shahe garabedian ; 9098397362
• MDR Report Key: 4781895
• MDR Text Key: 18544508
• Report Number: 9673241-2015-00296
• 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,Followup
• Report Date: 04/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: D-1266-01-S
• Device Catalogue Number: NR7TCSIY
• Device Lot Number: 17183086M
• Other Device ID Number: (01)10846835008500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2015
• 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