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

Model Number D134805

Device Problems Coagulation in Device or Device Ingredient (1096); Device Contamination with Body Fluid (2317)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2020

Event Type  malfunction  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent a pulmonary vein isolation (pvi) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a thrombus issue occurred.A thrombus was confirmed to be attached to the tip of the thermocool® smart touch® sf bi-directional navigation catheter electrode.The catheter was replaced.And the issue was resolved.No patient consequences were reported.Multiple attempts were made to obtain clarification regarding this complaint; however, no response was received.Should more information become available, it will be reviewed and processed accordingly.

Manufacturer Narrative

On 8/25/2020, biosense webster inc.Received additional information indicating a smartablate generator was used during the procedure.As such, the device has been added to field d11.Concomitant med.Product.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

The bwi product 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

On 7/21/2020, the product investigation was completed.It was reported that a patient underwent a pulmonary vein isolation (pvi) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a thrombus issue occurred.A thrombus was confirmed to be attached to the tip of the thermocool® smart touch® sf bi-directional navigation catheter electrode.The catheter was replaced.And the issue was resolved.No patient consequences were reported.Device evaluation details: the device was visually inspected and it was found in good conditions.The catheter was tested on the generator and the temperature and impedance values were observed within specifications.Per the reported event, an irrigation test was performed and the catheter failed.The irrigation tube was found bent inside the lure hub.A manufacturing record evaluation was performed for the finished device 30360803m number, and no internal actions related to the reported complaint was found during the review.The customer complaint cannot be confirmed.The root cause of the irrigation tube bent cannot be determined.Unit was inspected prior leaving the facility as there are functional tests and inspections at control points based on the process.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The product investigation was re-open to include details that clarify ¿the returned device was visually inspected and it was found in good conditions, no char was observed.¿ manufacturer¿s ref # (b)(4) initially this event was assessed as mdr reportable for a thrombus issue.During review on (b)(6)2021, a correction was noted to the assessment as this event should have been assessed as char which is not mdr reportable.Char is a physical phenomenon of radio frequency energy delivery and can be the normal result of the ablation process.The presence of char on the electrodes does not represent a serious injury in itself, nor is it necessarily the result of device malfunction.Therefore, the h6.Medical device problem code of ¿device contamination with body fluid¿ is being used to represent the issue.

• 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: 10223433
• MDR Text Key: 200408467
• Report Number: 2029046-2020-00803
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/08/2020

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: 03/10/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30360803M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2020
• Initial Date Manufacturer Received: 06/08/2020
• Initial Date FDA Received: 07/02/2020
• Supplement Dates Manufacturer Received: 07/02/2020; 07/21/2020; 08/25/2020; 05/20/2021
• Supplement Dates FDA Received: 07/15/2020; 08/10/2020; 09/18/2020; 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SMARTABLATE GEN. KIT (JAPAN)