MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D133601

Device Problems Coagulation in Device or Device Ingredient (1096); Insufficient Cooling (1130); Patient Device Interaction Problem (4001)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2020

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 reference number: (b)(4).

Event Description

It was reported that during an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter, the temperature would spike up around 50 degree (temperature cut-off), when coming on ablation.Sometimes, if the temperature cut-off of 50 degrees was not reached, the temperature would then rapidly decline back down to around 20-30 degrees, and sometimes, if the temperature cut-off of 50 degrees was reached, the ablation would then be cut-off.The catheter was then removed from the body, and it was noticed that there was coagulum residue near the thermistor location on the catheter.The catheter irrigation was still functioning normally.The catheter was cleaned of the residue, and then re-inserted, and the issue resolved.The procedure continued.No patient consequences were reported.No further information has been made available.The reported coagulum is an mdr-reportable issue.

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 reference number: (b)(4).

Manufacturer Narrative

On (b)(6) 2020, additional information was received which indicated the following: the patient did not exhibit any neurological symptom since the procedure was completed.The physician used different settings for ablations on the anterior and posterior sides of the left atrium.The settings while ablating the anterior were as follows: power control, power cut-off at 50 watts and temperature cut-off of 45c, time cut-off of 6 seconds.The settings while ablating the posterior were as follows: temp control, power cut-off of 25 watts and temperature cut off of 45c, time cut-off of 10 seconds.The impedance was roughly around the 140s (this was also the baseline impedance in the la), there was no unusual activity during ablation.The ablation duration was not greater than 60 nor than 120 seconds, the generator was preprogrammed with time cut-offs of 6 seconds (anterior) and 10 seconds (posterior).Posterior ablation settings do not use irrigation, the anterior settings were used with prescribed irrigation rates, the catheter issues occurred while ablating with anterior settings.Pre-ablation high temperature setting was 45 degrees c.Heparinized normal saline was used as irrigation fluid.Visitag settings in the anterior wall were respiratory gated, 2mm @ 4 seconds, fot of 25% at 4g.Tag size 2mm.Visitag settings in the posterior wall were respiratory gated, 1.5mm @ 5 seconds.Tag size 2mm.Impedance was used as coloring option.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, the product investigation was completed.It was reported that during an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter, the temperature would spike up around 50 degree (temperature cut-off), when coming on ablation.Sometimes, if the temperature cut-off of 50 degrees was not reached, the temperature would then rapidly decline back down to around 20-30 degrees, and sometimes, if the temperature cut-off of 50 degrees was reached, the ablation would then be cut-off.The catheter was then removed from the body, and it was noticed that there was coagulum residue near the thermistor location on the catheter.The catheter irrigation was still functioning normally.The catheter was cleaned of the residue, and then re-inserted, and the issue resolved.The procedure continued.No patient consequences were reported.Device evaluation details: the device was visually inspected, and it was found in normal condition.Then, 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, and no internal action related to the complaint was found during the review.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 clot 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).

• Brand Name: THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 10848893
• MDR Text Key: 219173875
• Report Number: 2029046-2020-01725
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835008982
• UDI-Public: 10846835008982
• Combination Product (y/n): N
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2021
• Device Model Number: D133601
• Device Catalogue Number: D133601
• Device Lot Number: 30405239M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Date Manufacturer Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SMARTABLATE GENERATOR.; SMARTABLATE PUMP.; SMARTABLATE REMOTE CONTROL.