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); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/06/2015

Event Type  malfunction  

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation.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.(b)(4).

Event Description

It was reported that a patient underwent a procedure with a smart touch bidirectional catheter and a temperature issue occurred.The temperature sensor was broken.Upon request additional information was received on the event.The issue was there was no temperature at all.The catheter was changed to a new catheter and the procedure was completed with no patient consequence.This event was originally assessed as not reportable as the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.On (b)(6) 2015 the product was received by bwi failure analysis lab for analysis and on visual inspection there was a rough bump on the lumen shaft with metal showing through the shaft near the peek housing transition.Multiple attempts have been made to obtain clarification to this finding.However, no further information has been made available.This lab finding has been assessed as reportable as the catheter integrity is not maintained and internal components are exposed to patient.The awareness date for this record is (b)(6) 2015 because that is when the damage was discovered.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent a procedure with a smart touch bidirectional catheter and a temperature issue occurred.Upon receipt, the catheter was visually inspected and a rough bump on lumen shaft with metal showing thru on shaft near peek housing transition was found which is why this complaint was reported to the fda.Due the damage an x-ray of the catheter was taken and it was noticed that the t bar had slightly slid down getting caught at tip.This condition contributes to the bump observed due to the fact that the t-bar is applying stress at that point.An internal corrective action was opened for the t bar issue.The returned device was then evaluated for electrical resistance and the thermocouple test failed.Further examination revealed that the thermocouple wires were disconnected inside the dome.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.

• 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: shahe garabedian ; 9098397362
• MDR Report Key: 4925023
• MDR Text Key: 22532707
• Report Number: 9673241-2015-00467
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 05/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Model Number: D-1327-05-S
• Device Catalogue Number: D132705
• Device Lot Number: 17089156M
• Other Device ID Number: (01)10846835009200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2014
• 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