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

Model Number D-1327-05-S

Device Problems Break (1069); Hole In Material (1293); Device Displays Incorrect Message (2591); Device Contamination with Chemical or Other Material (2944); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The bwi failure analysis lab received the device for evaluation.The returned device was visually inspected upon receipt and reddish material was found at the pebax area.Per this condition a scanning electron microscope (sem) testing was performed over the pebax area of catheter.A hole was found in the pebax area.It is possible that an unknown object hit and ruptured the pebax.Per the event reported, the catheter was evaluated for eeprom, and the functionality of the sensor catheter was tested on the carto 3 system.Eeprom data demonstrated the catheter was properly calibrated during manufacturing.The catheter was recognized by the carto 3 system; however the error 106 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 the internal damage at the sensor could not be determined.Regarding the damaged pebax, based on available analysis results; it cannot be identified whether the issue is related to an internal or an external cause.

Event Description

It was reported that a patient underwent a procedure with a smart touch bidirectional catheter.Initially, there was a force sensor error reflecting that there was no force value displayed.The procedure was completed with no patient consequence.This issue was assessed as not reportable as it 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 received the catheter for evaluation.During analysis it was discovered on (b)(6) 2017 that the pebax was observed damaged allowing reddish brown material inside this area.Therefore, a scanning electron microscope (sem) was performed.Sem results show that the pebax external surface presented evidence of scratches and pinhole.The pinhole was assessed as a reportable malfunction as there could have been a critical risk to the patient due to the potential of thrombus formation from exposure to internal parts of the catheter.The awareness date of this issue was (b)(6) 2017.

• 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: 6471954
• MDR Text Key: 72559296
• Report Number: 9673241-2017-00266
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: (01)10846835009200(11)160915(17)170831(10)17558198M
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: D-1327-05-S
• Device Catalogue Number: D132705
• Device Lot Number: 17558198M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2016
• 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