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.During the procedure, when cavotrhicuspid isthmus (cti) was completed, thrombus was confirmed attached to the tip of the thermocool® smart touch® sf bi-directional navigation catheter electrode.The catheter was replaced.And the issue was resolved.The procedure was successfully completed with no patient consequences.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.Products.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

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.During the procedure, when cavotrhicuspid isthmus (cti) was completed, thrombus was confirmed attached to the tip of the thermocool® smart touch® sf bi-directional navigation catheter electrode.The catheter was replaced.And the issue was resolved.The procedure was successfully completed with no patient consequences.On (b)(6)2020, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.On (b)(6)2020, during product evaluation, a thrombus was found on the tip of the catheter.This finding was reviewed and determined the complaint remains as mdr-reportable for the thrombus issue.Device evaluation details: the device evaluation has been completed.The device was visually inspected and it was found thrombus on tip.Additionally, the catheter was tested on the generator and the temperature and impedance values were observed within specifications.Then, a cool flow pump test was performed and it was found within specifications, the catheter was irrigating correctly, no irrigation issues were observed.A manufacturing record evaluation was performed and no internal action was found during the review.The customer complaint was confirmed.The root cause of the thrombus reported by the customer could be related to the usage of the device during the procedure, however this cannot be conclusively determined.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 product investigation was re-open to include details that clarify ¿the device was visually inspected and it was found char on the tip.The root cause of the char reported by the customer could be related to the usage of the device during the procedure, however this cannot be conclusively determined.The customer complaint was confirmed.¿ 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: 10223492
• MDR Text Key: 202101791
• Report Number: 2029046-2020-00804
• 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
• Report Date: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2023
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30360844M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK_SMARTABLATE GENERATOR.