MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV CATHETER

Model Number D-1347-01-SI

Device Problems No Display/Image (1183); Device Inoperable (1663)

Patient Problems Atrial Tachycardia (1731); Therapeutic Response, Decreased (2271)

Event Date 06/23/2015

Event Type  Injury  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.The device history record (dhr) has been reviewed and it was verified that device was manufactured in accordance with documented specifications and procedures.The ¿suspected medical device¿ reported in section d of 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 smart touch unidirectional approved under (b)(4).(b)(4).Methods: no testing methods performed.Results: no results available since no evaluation performed.Conclusion: device discarded by user, unable to follow-up.(b)(4).The device was not returned to bwi.

Event Description

This event is part of smart-sf clinical study.It was reported that a (b)(6) male patient underwent an afib procedure.During procedure the temperature was not being displayed and would not allow ablation.The catheter was replaced and the issue was resolved.More than 7 days after the procedure, the patient experienced left atrial re-entry tachycardia.The patient required re-ablation procedure and hospitalization.The issue was resolved without sequelae.The patient had a medical history of hypertension, atrial fibrillation and hyperlipidemia.The principal investigator assessed this event as not device related and possibly procedure related.This patient event was originally reported under report # 9673241-2015-00598.Additional information was received on september 03, 2015 that indicated that additional suspect devices were present.As such, the current report is being submitted and the awareness date for this suspect device is september 03, 2015.

Manufacturer Narrative

(b)(4) it was reported that a (b)(6) male patient underwent a afib procedure with a thermocool smarttouch sf ablation catheter and suffered left atrial re-entry tachycardia which required re-ablation procedure and hospitalization.Upon receiving, the catheter was visually inspected and it was found in normal conditions.Per the complaint, the catheter was tested for deflection and the catheter failed the test.Afterwards, an x-ray of the catheter was taken and it was noticed that the puller wire was broken near the anchor pin.The device was sent at sem analysis to determine the root cause of the puller wire fracture.Sem results showed that the wire was exposed to cutting events due to the pattern observed on the fracture.Also per sem analysis it concluded that in the first event the wire was partially cut and then in another event the wire was completely separated.The device history record (dhr) for the lot number 17235805l has been reviewed and it was verified that device was manufactured in accordance with documented specifications and procedures.The customer complaint has been verified for deflection issues however this is not related to the adverse event reported.

• Brand Name: THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV CATHETER
• Type of Device: THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV 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 ; 9497893837
• MDR Report Key: 5097726
• MDR Text Key: 26548681
• Report Number: 9673241-2015-00669
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Other
• Report Date: 06/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Model Number: D-1347-01-SI
• Device Catalogue Number: D134701SI
• Device Lot Number: 17235805L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2015
• 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
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 74 YR