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

Model Number D-1348-05-S

Device Problems Break (1069); Communication or Transmission Problem (2896); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2016

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 and the external surface of the pebax exhibited evidence of scratching and a fissure.It is possible that an unknown object hit and ruptured the pebax.Per the event, the catheter was tested for sensor, carto 3 functionality.The catheter failed during the calibration test and error 106 was displayed.Further examination showed that the sensor was within specifications.According to the calibration results and the sensor readings, the improper condition was attributed to a potential pc board failure.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 magnetic issues has been confirmed.An internal corrective action has been opened to investigate a potential pcb issues/intermittency.Regarding the pebax damage, 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 sf catheter.Initially, there was an out of box failure reflecting a location (magnetic) sensor was broken.The catheter was exchanged and the issue was resolved.The procedure was completed with no patient consequence.This event was assessed as not reportable.This issue was easy detectable by the user.The catheter was inoperable , since it could not be visualized on the carto system.The user will have to replace the catheter.The most likely consequence was an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death was remote.The catheter was received by the biosense webster failure analysis lab for assessment.During the first visual inspection on (b)(6) 2017 it was found that there was reddish material under the pebax.However, there were no visible damages.This issue was assessed as not reportable as the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.Additional assessment was performed on (b)(6) 2017 and the scanning electron microscope (sem) results reflect that the external surface of the pebax exhibited evidence of scratching and a fissure.It is possible that an unknown object hit and ruptured the pebax.Additional information was received stating that the issue noted was only that they did not see the catheter on the carto screen.The catheter was put through the patient¿s groin into the heart.It was thought that they used an 8.5fr agilis sheath.No mapping or ablation was performed.There was no difficulty experienced while maneuvering the catheter or during the withdrawal.The sem results have been assessed as reportable as the pebax integrity has been compromised.The awareness date is february 3, 2017.

• Brand Name: THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV 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: 6359909
• MDR Text Key: 68761807
• Report Number: 9673241-2017-00142
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: (01)10846835010183(11)160831(17)170831(10)17546597L
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P030031
• 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: 12/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• 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-1348-05-S
• Device Catalogue Number: D134805
• Device Lot Number: 17546597L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2016
• 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