MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number D133604IL

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/12/2018

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.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.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and a deflection issue occurred.A second catheter was used to complete the operation and no adverse patient consequences were reported.The deflection issue is not reportable.The potential risk that it could cause or contribute to a serious injury or death is remote.This issue is now mdr-reportable.The bwi failure analysis lab received the device for evaluation.The 8/17/2018 failure analysis lab fal findings of: white material stuck at approximately 0.4 cm from distal tip between tip electrode and ring 1.The issue of foreign material has been assessed as reportable.The awareness date has been reset to 8/17/2018.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and a deflection issue occurred.The investigational analysis has been completed.The device was inspected and white material was found stuck in the tip electrode and ring #1.Then, deflection testing was performed and the catheter failed.A failure analysis was performed and the catheter handle was opened.The puller wire was found broken, a closer inspection revealed that the polymide was bonded to the side arm assembly causing the deflection issue.Fourier transform infrared spectroscopy testing (ftir) was performed and the results showed that the material was not associated with the human-like material.No similar composition was found in the device.Based on bands, foreign material is primary composed of an organic salt; presumably a carbonate.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 failure from leaving the facility.The customer complaint was confirmed.The root cause of the foreign material observed cannot be determined since there is evidence that the device was manufactured in accordance with documented specification and procedures.Manufacture ref.No: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7877982
• MDR Text Key: 120706981
• Report Number: 2029046-2018-02060
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/12/2018

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: 02/21/2019
• Device Catalogue Number: D133604IL
• Device Lot Number: 30017234M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Initial Date Manufacturer Received: 08/17/2018
• Initial Date FDA Received: 09/14/2018
• Supplement Dates Manufacturer Received: 10/09/2018
• Supplement Dates FDA Received: 10/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1