MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D-1336-02-S

Device Problems Bent (1059); Break (1069)

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

Event Date 03/18/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigational analysis has been completed.Upon receipt of the catheter, there was a visual inspection and it was found that the shaft was bent with white stress marks about 44 cm from distal end of tip dome.Also, the shaft was bent and wrinkled with broken braid wire exposed about 84.4 cm from distal end of tip dome.This condition was not originally reported by the customer however an internal investigation is being held.Due to the exposed components, an electrical test was performed and catheter passed.Therefore, we can conclude all the electrical wires were perfectly insulated.Then per the event reported the catheter was tested on eeprom and calibration test and the catheter passed eeprom test but failed calibration test.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.The dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The customer complaint has been verified.An internal corrective action has been opened to investigate the thermocool smart touch broken shaft issue.

Event Description

It was reported that a patient underwent a procedure with a smart touch unidirectional catheter, and the biosense webster failure analysis lab noted the returned catheter condition of the exposed braid wire.It was originally reported by the physician that the smart touch unidirectional catheter has not been seen on the carto system.The carto system reported a magnetic navigation issue.The physician used another catheter to complete the procedure.There was no patient consequence.These issues were assessed as not reportable as the user will not be able to use the device and will have to replace it.The most likely consequence is an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death is remote.The biosense webster failure analysis noted on july 30, 2015 the returned product condition of the shaft bent and with slight white stress marks about 44 cm from distal end of tip dome.Also, the shaft was bent and wrinkled with an exposed broken braid wire about 84.4 cm from the distal end of tip dome.The shaft bent and with slight white stress marks about 44 cm from distal end of tip dome was assessed as not reportable.The integrity of the catheter is not compromised.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The shaft bent and wrinkled with an exposed broken braid wire about 84.4 cm from distal end of tip dome was assessed as reportable as there is an exposed braid wire.The catheter integrity is not maintained and internal components are exposed to patient.The awareness date for this issue is july 30, 2015.

• Brand Name: THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 5039321
• MDR Text Key: 25534745
• Report Number: 9673241-2015-00573
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 07/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: D-1336-02-S
• Device Catalogue Number: D133602
• Device Lot Number: 17149635M
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2014
• 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