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 Scratched Material (3020); Torn Material (3024)

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

Event Date 03/24/2016

Event Type  malfunction  

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 05/05/2016.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.The device history record (dhr) has been reviewed and it was verified that device was manufactured in accordance with documented specifications and procedures.(b)(4).

Event Description

This complaint is initially reported as a mdr not reportable force issue.It was reported that no force was measured by smart touch bidirectional catheter.The issue was resolved by replacing catheter.This complaint is re-assessed to a mdr reportable based on failure analysis lab findings on 05/05/2016.Between rings #2 and #3 the pebax was found torn/cut open exposing the helix coil and allowing reddish brown material inside of it.This is mdr reportable as the integrity of the catheter is compromised which posed risks to the patient of potential of thrombus formation from exposure of internal parts of the catheter.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 06/20/16.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

Additional information was received on 6/10/2016 stating that the previously returned catheter was not belonged to current complaint (manufacturer's ref.(b)(4)).Current supplemental report is providing device evaluation of correct catheter that described in the original event description: it was reported that no force was measured by smart touch bidirectional catheter.The issue was resolved by replacing catheter.(b)(4).It was reported that there was no force measured by tcst, no force calibration was possible.Changing the cable has not solved the problem but replace the tcst solved the problem.The returned device was visually inspected and it was found in normal conditions.The catheter was evaluated for the functionality of the magnetic and force sensors on carto system.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 a force sensor coil.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 of the force sensor coil could not be determinate.Based on available analysis results, it could not be identified whether the issue is related to an internal or an external cause.

• 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 ; 9497893837
• MDR Report Key: 5695573
• MDR Text Key: 47653189
• Report Number: 9673241-2016-00363
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: D-1327-05-S
• Device Catalogue Number: D132705
• Device Lot Number: 17405672M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2016
• Type of Device Usage: Initial
• Patient Sequence Number: 1