MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D134804

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/26/2018

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.Catheter was inspected and irrigation holes were found occluded.During analysis, the dome was opened and particles were observed inside and outside the dome.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for ischemic ventricular tachycardia with a thermocool® smart touch® sf bi-directional navigation catheter and foreign material was discovered.Upon removing the smarttouch sf catheter from the package, a clear-white glue-like substance was observed on the surface of the catheter between electrode rings 2 and 3.Smarttouch sf catheter integrity was maintained.Complaint catheter was replaced.Complaint catheter was not flushed or used on the patient.There was no patient consequence.This issue is mdr reportable.

Manufacturer Narrative

On (b)(6)2018 , the device history record (dhr) for the lot number 30004274l was reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Manufacturer's ref # (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure for ischemic ventricular tachycardia with a thermocool® smart touch® sf bi-directional navigation catheter and foreign material was discovered.Upon removing the smarttouch sf catheter from the package, a clear-white glue-like substance was observed on the surface of the catheter between electrode rings 2 and 3.Complaint catheter was not flushed or used on the patient.There was no patient consequence.Device evaluation details: the device evaluation has been completed.A picture provided by the customer was inspected and foreign material was observed on the catheter tip.Then, the complaint device was received and it was visually inspected; no foreign material was observed.The device was found in normal conditions.During a second visual inspection the irrigation holes were found occluded, the dome was opened and particles were observed inside and outside the dome.A fourier transform infrared spectroscopy test (ftir) was performed on the particles found and the results showed that it is primarily composed of a polyurethane (pu) based material.For this condition, the manufacture team performed an investigation in order to find the root cause.The investigation results showed that this issue is related to the manufacturing process; potentially originated during the pu application process for the irrigation tube-polyimide.During this point of the assembly, fresh pu is used and identified as the main contributor of the issue.As per the findings, communication about the complaint was made to reinforce the importance of an appropriate pu application to the production line associates involved in the related assembly process and inspections.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.During manufacturing process, all the catheters are inspected for visual damages before packaging.On line inspections and functional tests including irrigation test, are in place to prevent this type of failure from leaving the facility, however, during the investigation it was concluded that this issue was not detected by the inspections on the manufacturing line.The customer complaint was confirmed.Based on available analysis results, the issue found on the catheter dome appears to be caused by internal bwi operations, specifically, the manufacturing process, however, this appears to be an isolated case.Manufacturer's ref # (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7918920
• MDR Text Key: 123529928
• Report Number: 2029046-2018-02122
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 07/26/2018

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: No Information
• Device Expiration Date: 01/25/2019
• Device Catalogue Number: D134804
• Device Lot Number: 30004274L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Initial Date Manufacturer Received: 07/26/2018
• Initial Date FDA Received: 09/28/2018
• Supplement Dates Manufacturer Received: 10/17/2018; 07/26/2019
• Supplement Dates FDA Received: 10/22/2018; 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1