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 No Display/Image (1183); Hole In Material (1293); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2015

Event Type  malfunction  

Manufacturer Narrative

The bwi failure analysis lab received on (b)(6) 2015 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 thermocool® smart touch¿ bi-directional navigation catheter and no temperature was being displayed.During a procedure, the temperature of the catheter was no longer shown.Troubleshooting was performed by exchanging cable with no resolution, after the catheter was replaced with a new one, the issue was resolved.The procedure was completed without patient consequence.This event was originally considered non-reportable, however, bwi became aware of the product returned condition on (b)(6) 2015 and have reassessed this complaint as reportable due to the loss of integrity of this catheter and wires were exposed along the shaft within the usable length of the catheter.

Manufacturer Narrative

Due to additional investigation, an internal corrective action has been opened to investigate for tc breakage issue on the tip section for st and st sf.(b)(4).

Manufacturer Narrative

Additional information was received on october 2, 2015 from bwi representative regarding the product returned condition: the product condition was not noticed prior to use it on the patient and upon withdrawal.It was also not observed prior to sending it back to our analysis site.Confirmed no patient consequence occurred.(b)(4).It was reported that a patient underwent a procedure with a thermocool® smart touch¿ bi-directional navigation catheter and no temperature was being displayed.During a procedure, the temperature of the catheter was no longer shown.Troubleshooting was performed by exchanging cable with no resolution, after the catheter was replaced with a new one, the issue was resolved.The procedure was completed without patient consequence.This event was originally considered non-reportable, however, bwi became aware of the product returned condition on august 26, 2015 and have reassessed this complaint as reportable due to the loss of integrity of this catheter and wires were exposed along the shaft within the usable length of the catheter.The bwi failure analysis lab received the device for evaluation.Upon receipt, the catheter was visually inspected and it was found the shaft cracked at 11 cm from the client tip (metal exposed).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.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The customer complaint was confirmed.An internal corrective action has been opened to investigate for smarttouch broken shaft issues.

• 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: 5097058
• MDR Text Key: 26853773
• Report Number: 9673241-2015-00659
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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
• Type of Report: Followup
• Report Date: 06/25/2015

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: 02/29/2016
• Device Model Number: D-1327-05-S
• Device Catalogue Number: D132705
• Device Lot Number: 17194388M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/10/2015
• 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