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 05/21/2020

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 cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a thrombus/clot issue occurred.It was reported by the customer that during the procedure, and after pulmonary vein isolation (pvi), a thrombus was confirmed to be attached to the tip electrode of the thermocool® smart touch® sf bi-directional navigation catheter.The catheter was replaced, and the issue was resolved.The procedure was completed without patient consequences.Multiple attempts were made to obtain further information regarding this event; however, no response was received.Should more information become available, it will be reviewed and processed accordingly.

Manufacturer Narrative

On 7/6/2020, the product investigation was completed.It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a thrombus/clot issue occurred.It was reported by the customer that during the procedure, and after pulmonary vein isolation (pvi), a thrombus was confirmed to be attached to the tip electrode of the thermocool® smart touch® sf bi-directional navigation catheter.The catheter was replaced, and the issue was resolved.The procedure was completed without patient consequences.Device evaluation details: the device was visually inspected, and it was found in good normal conditions, during a second closer inspection it was confirmed, no was found thrombus on the tip, it could be remover during decontamination process.Electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.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 for the finished device 30356826m number, and no internal actions related to the reported complaint condition were identified.The customer complaint cannot be confirmed since the device was found working correctly and no evidence of thrombus residues were observed on the catheter however, 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 reference number: (b)(4).

Manufacturer Narrative

On (b)(6) 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 product investigation was re-open to include details to clarify that ¿no char was found on the catheter tip;¿ during visual analysis/inspection of the device.Manufacturer¿s ref # (b)(4) initially this event was assessed as mdr reportable for a thrombus/clot 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: 10160949
• MDR Text Key: 195522255
• Report Number: 2029046-2020-00708
• 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: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30356826M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SMARTABLATE GEN. KIT (JAPAN).; THMCL SMTCH SF BID, TC, D-F.