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

Model Number D134801

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 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's ref.#(b)(4).

Event Description

It was reported that a patient underwent cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter where a thrombus formation occurred.After about 5 hours since the thermocool® smart touch® sf bi-directional navigation catheter was used, a steam pop occurred during the ablation of the lower posterior wall of the left atrium.When the thermocool® smart touch® sf bi-directional navigation catheter was checked after the case, a thrombus was attached to the tip.There was no effect on the procedure.The physician¿s commented nothing in particular.There was no report of patient consequence nor extended hospitalization.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Should more information becomes available in the future; the reportability decision will be reassessed.

Manufacturer Narrative

It was reported that a patient underwent cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter where a thrombus formation occurred.After about 5 hours since the thermocool® smart touch® sf bi-directional navigation catheter was used, a steam pop occurred during the ablation of the lower posterior wall of the left atrium.When the thermocool® smart touch® sf bi-directional navigation catheter was checked after the case, a thrombus was attached to the tip.There was no effect on the procedure.The physician¿s commented nothing in particular.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, biosense webster inc.Received additional information about the patient and event.It was reported that there were no error messages and/or impedance rises reported during the case and the patient has not exhibited an neurological symptoms.A smartablate generator was in use during the procedure, therefore, it has been added to field d11.Concomitant med.Products.Device evaluation details: the device evaluation has been completed.The returned device was visually inspected, and it was found the thrombus residues on the distal dome.The findings were reviewed and determined they continue to be deemed mdr reportable.Then, per the event, the catheter was tested for generator compatibility and it was found within specifications.An irrigation test was performed, and the catheter failed: no irrigation was observed on the distal part of the dome, the distal holes were occluded by thrombus residues.A manufacturing record evaluation was performed for the finished device 30368219m number, and no internal action related to the complaint was found during the review.The reported thrombus issue has been confirmed.The root cause of 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

On (b)(6) /2020, it was discovered that the concomitant "smartablate generator" was inadvertently omitted from the supplemental mdr.The device has now 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 that clarify ¿the returned device was visually inspected, and it was found char residues on the distal dome.The reported char issue has been confirmed.The root cause of the issue could be related to the usage of the device during the procedure, however this cannot be conclusively determined.¿ manufacturer¿s ref # pc-(b)(4) initially this event was assessed as mdr reportable for a thrombus issue.During review on 5/20/2021, 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: 10451658
• MDR Text Key: 204731290
• Report Number: 2029046-2020-01100
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• 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: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2021
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30368219M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2020
• 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)