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 Hole In Material (1293); Increase in Pressure (1491); Device Contamination with Chemical or Other Material (2944)

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

Event Date 04/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The bwi failure analysis lab received the device for evaluation.The returned device was visually inspected and it was found reddish material under the pebax.The catheter was evaluated for eeprom, and the functionality of the sensor catheter was tested on carto system.Eeprom data demonstrates the catheter was properly calibrated during manufacturing.The catheter was recognized by carto 3 system.However, error 106 was displayed.The catheter was then dissected and it was determined that the root cause was an internal failure of the sensor.For the condition observed, a scanning electron microscope (sem) testing was performed and the results showed evidence of a hole on the surface of the pebax.It is possible that damage was generated with an unknown object.No other anomalies were observed.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.During the manufacturing process, all the catheters are inspected for visual damages before packaging.On line inspections and functional tests are in place to prevent this type of damage from leaving the facility.The customer complaint has been verified.The root cause of the loss of electrical continuity at the sensor could not be determined.The root cause of damage cannot be determined.

Event Description

It was reported that a patient underwent a procedure with a smart touch unidirectional catheter.During the procedure, the pressure value was high as it was over 20g.The catheter was exchanged.The procedure was completed with no patient consequence.This issue was highly detectable.The potential risk that it could cause or contribute to a death or serious deterioration in state of health was remote.The biosense webster failure analysis lab discovered on (b)(6) 2017 reddish material under the pebax.Since no damage was found on the pebax, this issue was assessed as not reportable as the potential that it could cause or contribute to a death, serious injury, or other significant adverse event was remote.After further assessment, it was discovered on (b)(6) 2017, reddish material inside the pebax in addition to a hole on the pebax.The not reportable assessment for the issue with reddish brown material inside the pebax still stands.The issue with the hole on the pebax was assessed as reportable.The presence of a hole creates a break in the integrity of the catheter.Therefore, the risk to the patient was critical due to the potential of thrombus from exposure to the internal catheter.The awareness date was reset to (b)(6) 2017.

• 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: 6812118
• MDR Text Key: 83652022
• Report Number: 9673241-2017-00668
• 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
• Report Date: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: D-1336-04IL-S
• Device Catalogue Number: D133604IL
• Device Lot Number: 17631346M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/09/2017
• Initial Date FDA Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2017
• 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