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

Model Number D-1327-04-S

Device Problems Device Displays Incorrect Message (2591); Material Integrity Problem (2978); Torn Material (3024)

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

Event Date 08/26/2016

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 ablation procedure with a thermocool® smarttouch® bi-directional navigation catheter and the physician reported a temperature sensor error in which ablation was unavailable.The catheter was changed and the procedure was completed with no patient consequence.This event was originally assessed as not mdr reportable because potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.On september 16, 2016, the biosense webster failure analysis lab received the device for analysis and found the pebax was torn and ripped with metal showing at distal end of ring #2.Multiple attempts have been made to obtain clarification for the lab findings; however, no further information has been made available.This event is mdr reportable because the patient can be exposed to internal parts putting them at risk for issues such as thrombosis or stroke.The awareness date has been reset to the date of the reportable finding september 16, 2016.

Manufacturer Narrative

(b)(4) it was reported that a patient underwent an ablation procedure with a thermocool smarttouch bi-directional navigation catheter and the physician reported a temperature sensor error in which ablation was unavailable.Upon receiving, the catheter was visually inspected and the pebax area was found torn and ripped with the helix exposed, which is why this complaint was mdr reportable.Per this condition, a scanning electron microscope (sem) testing was performed over the area and it was found that there was evidence of scratching, pinhole and rupture induced by an unknown object.The returned device was then evaluated for electrical resistance and the thermocouple test failed.Further examination revealed that the thermocouple wires were broken at the tip section causing the temperature issue.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 regarding a temperature issue has been confirmed.An internal corrective action was created to address thermocouple breakage on the tip section for st and st sf catheters.Pebax damage found, based on available analysis results cannot be identified whether the issue was related to an internal or an external cause.

• Brand Name: THERMOCOOL® SMARTTOUCH® BI-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: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6014205
• MDR Text Key: 57453371
• Report Number: 9673241-2016-00689
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009194
• UDI-Public: (01)10846835009194(11)160621(17)170531(10)17500193M
• 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
• Type of Report: Initial,Followup
• Report Date: 08/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: D-1327-04-S
• Device Catalogue Number: D132704
• Device Lot Number: 17500193M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2016
• 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