MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Model Number D-1336-04IL-S

Device Problems Device Displays Incorrect Message (2591); Material Protrusion/Extrusion (2979); Torn Material (3024)

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

Event Date 11/18/2016

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 smart touch unidirectional catheter where the catheter experienced a magnetic sensor error.The catheter was exchanged for a new one, and the procedure continued with no patient consequence.On (b)(6) 2017, the biosense webster failure analysis lab received the device, and found that the pebax was torn open with metal showing between the first and second electrodes.It is unknown if the catheter was withdrawn with any difficulty that may have caused the damage.The condition of the catheter was not noted prior to use or prior to returning it for analysis.It is unknown what sheath was in use.When a catheter exhibits a magnetic sensor error, it cannot be used and must be replaced.The catheter is inoperable, and this is highly detectable by the user.The potential that this error could contribute to an adverse event is remote.However, patient exposure to the internal components of the catheter presents a risk of thrombus formation.As a result, this event is mdr reportable.The reportable lab findings were discovered on (b)(6) 2017, making it the awareness date for this event.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an ablation procedure with a thermocool smart touch unidirectional catheter where the catheter experienced a magnetic sensor error.The catheter was exchanged for a new one, and the procedure continued with no patient consequence.On (b)(6) 2017, the biosense webster failure analysis lab received the device, and found that the pebax was torn open with metal showing between the first and second electrodes.The returned device was visually inspected upon receipt, and the pebax was found torn open with the internal components exposed.Per this condition, scanning electron microscope (sem) analysis was performed over the pebax, which was confirmed to be scratched/ruptured.It is possible that an unknown object hit and ruptured the pebax.No evidence of mechanical damage was observed.Per the reported event, the catheter was evaluated for eeprom, carto 3 system compatibility and sensor functionality.The catheter was recognized by the carto 3 system with no error messages and proper visualization.Eeprom data demonstrates that the catheter was properly calibrated during manufacturing.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 magnetic sensor error has not been confirmed.However, the pebax was found damaged.Based on available analysis results, it cannot be identified whether the issue is related to an internal or an external cause.

• Brand Name: THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• 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: 6267965
• MDR Text Key: 65781758
• Report Number: 9673241-2017-00066
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: D-1336-04IL-S
• Device Catalogue Number: D133604IL
• Device Lot Number: 17509345M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2016
• 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