MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC (IRWINDALE) 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); Leak/Splash (1354); Moisture Damage (1405); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/27/2015

Event Type  malfunction  

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) procedure with a smart touch bidirectional catheter.During the bwi failure analysis visual inspection, it was found that there was a pinhole between the dome and electrode 2.During the procedure, the stockert 70 system was not displaying a temperature when the catheter was plugged into the patient interface unit (piu).The ablation cable and the redel cable were replaced without resolution.Also the catheter did not deflect as far as it should.The fluid also leaked at the hub port on the handle when the coolflow pump was activated.The ablation catheter was replaced and the issues were resolved.The procedure was continued with no patient consequences.These original reported issues were assessed as not reportable.The bwi failure analysis lab received the catheter on february 10, 2015.It was found that there was dark red material inside of the pebax.Upon request, additional clarification was provided on the returned catheter condition.There was no difficulty known when withdrawing the catheter from the patient.It was confirmed that there was no patient consequence.This condition was not noted prior to use, upon withdrawal or during shipping it back to bwi.The 8.5 mobicath or 8.5 agilis sheath were used.No holes or opening were found on the pebax.There were no exposed inner components.The pebax was not compromised.No patient consequence.Therefore, this issue was assessed as not reportable.After further analysis of the catheter, on march 24, 2015, the bwi failure analysis noted that there was a pinhole between the dome and electrode 2.Therefore, this additional finding has been assessed as reportable.The awareness date for this finding is march 24, 2015.

Manufacturer Narrative

(b)(4).Upon receipt, the catheter was visually inspected and dark red material was found inside the pebax.Due to this finding, a scanning electron microscope (sem) test was performed and it was found that the external surface of pebax exhibited evidence of sinking of material at the surrounding areas of a pinhole.This damage might contribute to let the dark red material in at the pebax area.An internal corrective action has been opened to investigate this type of pebax damage.Further information received indicates that the dark red material was not noticed by the customer.Per the temperature issue reported, the catheter was tested for electrical performance, temperature response and stockert compatibility and it was found within specifications.Also an irrigation test was performed; however no leakage was observed during the test.Therefore per the deflection problem reported, the catheter was tested for deflection and the catheter failed.Afterwards, the catheter was dissected and the puller wire was found detached from the ferrule inside the handle, causing the deflection issue.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.An internal corrective action has been opened to investigate this type of pebax damage.

• Brand Name: THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: shahe garabedian ; 15715 arrow hwy; irwindale, CA 91706 ; 9098397362
• MDR Report Key: 4724035
• MDR Text Key: 15344377
• Report Number: 2029046-2015-00116
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2015
• Device Model Number: D-1327-05-S
• Device Catalogue Number: D132705
• Device Lot Number: 17060798M
• Other Device ID Number: (01)10846835009200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2014
• 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