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

Model Number D134801

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

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

Event Date 03/12/2021

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Initial reporter phone: (b)(6).Manufacturer's ref.(b)(4).

Event Description

It was reported that a patient underwent a pulmonary vein isolation (pvi) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a thrombus issue occurred.It was reported that during pvi with this catheter, temperature limit worked.The thermocool® smart touch® sf bi-directional navigation catheter was removed from the cardiac cavity and checked, thrombus was attached to the tip of the catheter.On the smartablate generator display, the flow rate was correct and a flush was performed, but no saline is injected.When the pump was checked, the tube was found entangled, and when flushed, it was rotating backward.The tube was removed, replaced again, and flushed.However, a thrombus was stuck in the catheter's irrigation hole and cannot be flushed.The issue was resolved by changing the catheter to another one.After that, although the catheter was inserted into the cardiac cavity and ablation was conducted, there were no additional problems.There were no patient consequences.The physician commented that the saline did not flow so the catheter was thrombosed.Additional information received indicated no error message were observed, but there was a temperature over the limit issue.The smartablate generator was set to power control mode.Regarding anticoagulation it was reported that in japan, patient was anticoagulated during the procedure usually and normal heparinized saline is used during the procedure.It was not reported the catheter was used inappropriately/not according to the instructions for use (ifu).No neurological symptom was confirmed.The customer¿s reported high temperature issue is not considered to be mdr reportable since there is no indication that the user defined cut off was exceeded and potential that it could cause or contribute to a death, serious injury, or other significant adverse event, is remote.

Manufacturer Narrative

The bwi product analysis lab received the complaint device for evaluation.Initial visual inspection found the device in good normal condition.The product 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 ref.# (b)(4).

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference # (b)(4).Correction: initially this event was assessed as mdr reportable for a blood 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, the h6.Medical device problem code remains as ¿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: 11639538
• MDR Text Key: 247252415
• Report Number: 2029046-2021-00549
• 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
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2021
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30448215M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• 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-D; UNKNOWN PUMP; UNKNOWN TUBE