MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER; SIMILAR DEVICE D132701, PMA # P030031/S053

Model Number D-1348-05-S

Device Problems Break (1069); Device Contamination with Body Fluid (2317); Device Displays Incorrect Message (2591)

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

Event Date 05/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The ¿suspected medical device¿ reported in this report is not marketed in usa or approved by the fda.However, it is being reported as biosense webster considers this as a similar device to thermocool smarttouch approved under p030031.Manufacturer's ref.No: (b)(4).The bwi failure analysis lab received the device for evaluation.Upon receipt, the catheter was visually inspected and the catheter was observed in good condition; however during a second visual inspection during the analysis a damage was observed on the sensor sleeve (pebax) allowing reddish brown material inside of it.A scanning electron microscope (sem) test was performed and results showed that there was evidence of a hit an rupture induced by an unknown object.The catheter was tested for electrical performance and it was found within specifications.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 signal error cannot be confirmed.The customer complaint regarding a blood under the silicon has been verified.Based on available analysis results, it could not 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, during the procedure the carto 3 system and the recording system showed that there is no body surface (bs) and intracardiac (ic) signals.However, there were signals on the defibrillator.They checked the bs leads and everything was fine.After they disconnected the bs cable from the carto, the system gave an error message of ¿the leakage current has stopped¿.They replaced the catheter and it resolved the issue.It was noticed that there was blood under the silicon cover of the spring.There was no physical damage observed on the distal end of the catheter.The procedure was completed with no patient consequence.These issues were assessed as not mdr reportable as the risk to the patient was low.The patient's heart rhythm was still visible to the operator.The error message populating was highly detectable.Foreign material was found underneath the pebax.However, there was no damage to the pebax integrity.The biosense webster failure analysis lab observed on june 30, 2016 during the second visual inspection, blood was in the pebax and the pebax was damaged.Since the pebax was damaged, the integrity of the catheter has been compromised.Therefore, this returned catheter condition has been assessed as a reportable malfunction.The awareness date is reset to june 30, 2016.

• Brand Name: THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER
• Type of Device: SIMILAR DEVICE D132701, 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: 5827687
• MDR Text Key: 51504628
• Report Number: 9673241-2016-00457
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: HU
• 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: 05/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Model Number: D-1348-05-S
• Device Catalogue Number: D134805
• Device Lot Number: 17340820L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2015
• 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