MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D-1336-02-S

Device Problems Signal Artifact/Noise (1036); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2015

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 pulmonary vein isolation procedure with a smart touch bidirectional catheter and a noise issue occurred.After four hours of procedure there suddenly was noise on all intracardiac electrocardiogram channels and the mapping catheter.Troubleshooting revealed that the catheter was causing this noise.The catheter was replaced and the procedure was successfully completed.There was no patient consequence.This event was originally assessed as not reportable as the patient's heart rhythm is still able to be monitored and the risk to the patient is low.On july 13, 2015 the catheter was received by bwi failure analysis lab for analysis.During visual inspection there was reddish material found under the pebax and a small hole was also found in the pebax.This finding is indicative of a reportable event as the catheter integrity is no longer maintained.The awareness date for this record is july 13, 2015 because that is when the product was returned.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent a pulmonary vein isolation procedure with a smart touch bidirectional catheter and a noise issue occurred.The returned device was visually inspected and reddish material was found under the pebax.A small hole was also found in the pebax which is why this complaint was reported to the fda.Scanning electron microscope (sem) results showed clear evidence of mechanical damage on the dome and electrode rings 2 and 3 which resulted in scratches.Moreover, the pebax presented evidence of scratches.Considering that the pebax damage section is straightly aligned and near the scratches on electrode ring #3, it is very likely that the unknown object which caused the mechanical damage on the dome and electrode rings # 2 and 3, caused such damages on the pebax as well.No other anomalies were found.This type of pebax damage has been investigated under an internal corrective action.The device was then evaluated for electrical resistance and current leakage and it failed on electrode # 2 and 3.Further examination revealed that the lead wire #2 and 3 was broken causing the improper signal condition.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 has been verified.

• Brand Name: THERMOCOOL® SMARTTOUCH® UNI-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: 4964187
• MDR Text Key: 24670522
• Report Number: 9673241-2015-00502
• 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
• Report Date: 06/15/2015

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: 02/28/2016
• Device Model Number: D-1336-02-S
• Device Catalogue Number: D133602
• Device Lot Number: 17198995M
• Other Device ID Number: (01)10846835009002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2015
• 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