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

Model Number D134805

Device Problems Complete Blockage (1094); Insufficient Cooling (1130); Device Contamination with Body Fluid (2317)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information received indicates that the device is not available for return as the catheter is in the possession of the hospital; therefore, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30506854m number, and no internal actions related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that an unknown patient underwent an atrial flutter (afl) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a clot issue occurred.During the right sided aflutter ablation (right sided so not anticoagulated and unknown act), they had a temperature rise when radio frequency energy was applied to the thermocool® smart touch® sf bi-directional navigation catheter.The catheter was removed, and it was found to have a clotted tip.It was then observed that the smartablate tubing had become detached, and the catheter was not irrigating.The catheter was replaced and the procedure was continued and subsequently completed.Error on ablation that the temperature was high.Physician noticed tubing was disconnected so the catheter was pulled out of the body and it was clotted.Irrigation tubing had disconnected from the back of the catheter, so flow was not on to the catheter.Power control, temp cutoff of 40, power cutoff of 35.The correct catheter settings were selected on the generator and the pump was switching from low to high flow during ablation, but it was not delivered to catheter due to unattached tubing.The duration of ablation used was not greater than 60 seconds because the system shut off due to immediate temperature rise due to no irrigation.There was no contact force under 20.Heparinized saline was used but was not being delivered to catheter.Ablation stopped before visitag occurred.A new catheter was used because first catheter was occluded after irrigation was disconnected.The patient has not exhibited any neurological symptoms since the procedure was completed.The clot was assessed as mdr reportable.The irrigation issue was assessed as not mdr reportable.Occlusion or no irrigation is highly detectable by the physician.The most likely consequence is an intraprocedural delay the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The high temperature issue was assessed as not mdr reportable.Since generator stopped delivering radio frequency, the most likely consequence was an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.

Manufacturer Narrative

Manufacturer's reference number: (b)(4) this event was assessed as mdr reportable for a clot 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, updated under ¿h6.Medical device problem code¿ from ¿coagulation in device or device ingredient¿ to ¿device contamination with body fluid¿.

• 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: 11709018
• MDR Text Key: 264709796
• Report Number: 2029046-2021-00638
• 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
• Type of Report: Initial,Followup
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30506854M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BRAND CATHETER; UNKNOWN BRAND GENERATOR; UNKNOWN BRAND PUMP; UNK_SMARTABLATE PUMP TUBING