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

Model Number D-1197-16-S

Device Problems Bent (1059); Crack (1135); Device Inoperable (1663); Invalid Sensing (2293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/16/2016

Event Type  malfunction  

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).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a navistar thermocool catheter.During the procedure, the catheter could not apperceive the magnetic signal.The catheter was exchanged.The procedure was completed with no patient consequence.This reported issue was easily detectable by the user.The catheter was inoperable, since it cannot be visualized on the carto system.The user will have to replace the catheter.The most likely consequence was an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death was remote.The biosense webster failure analysis lab received the catheter for analysis on october 18, 2016 and discovered that the peek housing was bent and cracked open leaving internal parts exposed on proximal side of electrode ring #1.This catheter condition was not observed previously.There was no resistance or difficulty during insertion or removal of the catheter.It was not known if the catheter was pre-shaped.The sheath was not known.There was no patient consequence.This returned catheter condition has been assessed as a reportable malfunction as the risk to the patient was critical due to the potential of thrombus formation from exposure of internal parts of the catheter.Therefore, the awareness date was reset to october 18, 2016.

Manufacturer Narrative

During the product analysis, the lot number of 17409390m was discovered.Therefore, the following have been updated: manufactured date, expiration date, udi#.(b)(4).

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with a navistar thermocool catheter.During the procedure, the catheter could not apperceive the magnetic signal.The catheter was exchanged.The procedure was completed with no patient consequence.Upon receipt, the catheter was visually inspected and the peek housing at the tip area was found cracked and open, leaving the internal parts exposed.A scanning electron microscope (sem) test was performed and the results show that the external surface of the peak housing exhibited evidence of scratches and rupture.Per the event reported, the catheter was evaluated for eeprom, and the functionality of the sensor catheter was tested on carto 3 system.The eeprom data demonstrates the catheter was properly calibrated during manufacturing.The catheter was recognized by carto 3 system; however the error 105 was displayed.The catheter was then dissected and it was determined that the root cause was an internal failure of the sensor.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 has been verified.The root cause of internal damage at the sensor and peek housing damage could not be determined.

• Brand Name: NAVISTAR® THERMOCOOL®
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6091786
• MDR Text Key: 60083556
• Report Number: 2029046-2016-00243
• 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: Initial,Followup,Followup
• Report Date: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: D-1197-16-S
• Device Catalogue Number: NI75TCDH
• Device Lot Number: UNKNOWN_D-1197-16-S IRW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2016
• 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