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

Model Number D134805

Device Problems Signal Artifact/Noise (1036); Coagulation in Device or Device Ingredient (1096); Device Contamination with Body Fluid (2317)

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

Event Date 08/27/2020

Event Type  malfunction  

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).

Event Description

It was reported that a patient underwent a afib - paroxysmal procedure with a thermocool® smart touch® sf bi-directional navigation catheter where noise on ecg signals and char occurred.It was reported that electrogram noise displayed on both the carto 3, and recording system ablation signals.When the ablation catheter was removed from the patient there was char/coagulum seen on the tip of the catheter.The catheter was cleaned off and reinserted.The ablation cable, the indifferent electrode, and 12 lead body surface ecg cables were replaced without resolution.The catheter was replaced and the issue resolved.It was reported that the root cause of the issue was catheter-related, and the carto 3 system is operating per specs.There were no patient consequence.The system did not present any error messages.There were no issues related to temperature and flow on the catheter.All settings were per instructions for use.The physician¿s preferred act target is 350-400 sec but the exact value was not noted.The contact force was not noted but lesions longer than 60 sec and higher than 25 grams of contact force would be contrary to physician¿s general practice.The irrigation setting were used with prescribed parameters.Pre-ablation high setting was 2 sec.Heparinized normal saline was used for irrigation.Carto visitag module settings were respiratory gating, 3 mm over 5 seconds for stability, 25% of 5 grams with 3 mm tag.Impedance drop 5-15 ohms was used as additional filter.The coagulum reported was assessed as a reportable mdr issue.The noise on ecg signals is not reportable as the risk to the patient is low.

Manufacturer Narrative

On (b)(6) 2020, the product investigation was completed.It was reported that a patient underwent a afib - paroxysmal procedure with a thermocool® smart touch® sf bi-directional navigation catheter where noise on ecg signals and char occurred.It was reported that electrogram noise displayed on both the carto 3 and recording system ablation signals.When the ablation catheter was removed from the patient there was char/coagulum seen on the tip of the catheter.The catheter was cleaned off and reinserted.The ablation cable, the indifferent electrode, and 12 lead body surface ecg cables were replaced without resolution.The catheter was replaced and the issue resolved.It was reported that the root cause of the issue was catheter-related, and the carto 3 system is operating per specs.There were no patient consequences.Device evaluation details: the device was visually inspected and it was found in good conditions.Thrombus was not observed, it could be lost during decontamination process.Then, 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 and no internal actions related to the reported complaint were identified.The customer complaint cannot be confirmed, due the device was found working correctly.The root cause of the thrombus could be related to the usage of the device during the procedure.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 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: 10575134
• MDR Text Key: 208198693
• Report Number: 2029046-2020-01270
• 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,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30407452M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; UNSPECIFIED ECG CABLE; UNSPECIFIED RECORDING SYSTEM; CARTO 3 SYSTEM; UNSPECIFIED ECG CABLE; UNSPECIFIED RECORDING SYSTEM