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

Catalog Number D132704

Device Problems Detachment of Device or Device Component (2907); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2018

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.Manufacture ref no: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for left atrial flutter with a thermocool® smart touch¿ bi-directional navigation catheter, and a catheter tip partially separated issue occurred.The defect happened between the proximal electrode and distal tip electrode.The physician felt like the catheter was getting stuck in between the st.Jude medical sl1 sheath and felt the catheter separated from the electrode.Catheter replacement resolved the issue.No adverse patient consequences were reported.The issue of catheter tip partially separated has been assessed as mdr reportable.On 12/19/2018, the bwi product analysis lab (pal) received the device for evaluation and found white material stuck from the distal side tip dome, approximately 5mm underneath ring 1.The observed foreign material has been assessed as mdr reportable.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure for left atrial flutter with a thermocool® smart touch¿ bi-directional navigation catheter, and a catheter tip partially separated issue occurred.The investigational analysis completed on 1/21/2019.The device was inspected and white material was observed stuck in the ring.The catheter outer diameter was measured and ring #1 failed due to the material observed underneath.The other rings were found within specification.On 1/16/2019, fourier transform infrared spectroscopy test (ftir) was performed and the results showed reveled the white particle is primarily composed of a polyethylene-based material with barium sulfate- based material.This composite material is widely used as radio pacifier a long medical divide industry.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 are in place to prevent this type of damage from leaving the facility.The customer complaint was confirmed.The root cause of the damage on the ring and the white material observed cannot be determined since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the manipulation with the sheath.However, this cannot be conclusively determined.Manufacture reference no: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure for left atrial flutter with a thermocool® smart touch¿ bi-directional navigation catheter, and a catheter tip partially separated issue occurred.Additional information was received on 1/3/19, indicating the device history record (dhr) has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Manufacture ref no: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ 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: 8211266
• MDR Text Key: 132567121
• Report Number: 2029046-2019-02513
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009194
• UDI-Public: 10846835009194
• Combination Product (y/n): N
• PMA/PMN Number: P030031/S053
• 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: 12/05/2018

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: Health Professional
• Device Expiration Date: 08/05/2019
• Device Catalogue Number: D132704
• Device Lot Number: 30090412M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 01/03/2019
• Supplement Dates Manufacturer Received: 01/03/2019; 01/16/2019
• Supplement Dates FDA Received: 01/18/2019; 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1