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

Catalog Number D132705

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2018

Event Type  malfunction  

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 7/9/2018.Initial visual analysis indicated the catheter tip is stuck in deflection position, however, no visual damages.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 manufactured date and expiration date have been provided.Therefore, expiration date and device manufacture date have been populated.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for ischemic ventricular tachycardia with a thermocool® smart touch¿ bi-directional navigation catheter wherein the deflection became stuck and a medical device entrapment issue occurred.There were no patient consequences.During the procedure, while the catheter was in the aorta, the catheter puller wire lost the ability to deflect and was stuck in maximum deflection on the f curve.Although there was difficulty removing the catheter, the physician was able to straighten the curve with the sheath and remove the catheter.The thermocool® smart touch¿ bi-directional navigation catheter was replaced and the issue resolved.Procedure continued without patient consequence.There were no issues with the knob/piston being able to be turned.There was no ring or other physical damage observed at the distal end of the catheter.The issue of the deflection becoming stuck is considered a reportable malfunction.The issue of medical device entrapment is not a reportable event since the device was able to be removed without surgical intervention.

Manufacturer Narrative

On 7/24/2018, it was noticed a correction was needed for a statement provided in the initial 3500a mdr report.The statement is being corrected from "the manufactured date and expiration date have been provided.Therefore, fields expiration date and device manufacture date have been populated." to "still pending is the manufactured date and the expiration date.Therefore, a supplemental report will be submitted to update the expiration date and manufactured date." manufacturer's ref # (b)(4).

Manufacturer Narrative

On 8/9/2018, the manufactured date and expiration date were provided.Therefore, expiration date and device manufacture date have been populated.The device history record (dhr) for the lot number 30032907m has been 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¿ bi-directional navigation catheter wherein the deflection became stuck and a medical device entrapment issue occurred.The investigational analysis has been completed.The catheter was visually inspected, and the tip was found bent in curve f.No visual damage observed.Deflection test was performed, and it was found within specifications for only one curve, as the catheter was deflecting correctly, however, the other curve failed.A failure analysis was performed, and the catheter was dissected on the handle area and the puller wire was found detached from the brass ferrule causing the deflection issue.For the bent condition, the catheter was observed under the x-ray machine and the two t bars were observed in the correct position.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 bent observes could be related to the handling of the device during the procedure.Manufacturer's 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: 7714675
• MDR Text Key: 114945525
• Report Number: 2029046-2018-01840
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• 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,Followup
• Report Date: 06/26/2018

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: Health Professional
• Device Expiration Date: 03/12/2019
• Device Catalogue Number: D132705
• Device Lot Number: 30032907M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Initial Date Manufacturer Received: 06/26/2018
• Initial Date FDA Received: 07/24/2018
• Supplement Dates Manufacturer Received: 07/24/2018; 08/09/2018; 08/16/2018
• Supplement Dates FDA Received: 07/25/2018; 08/13/2018; 09/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1