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

Model Number D133602

Device Problems Contamination /Decontamination Problem (2895); Electrical Shorting (2926)

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

Event Date 06/29/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).The biosense webster, inc.Product analysis lab received the device for evaluation.The device evaluation summary was completed on 11/9/2020.The device was visually inspected and it was found that there was foreign material trapped under the electrode and corrosion on the connector.Then, magnetic sensor functionality was tested on carto and the catheter was properly visualized and no errors were observed.Then, a cool flow pump test was performed and it was found within specifications.The catheter was irrigating correctly.No leakage issues were observed.A manufacturing record evaluation was performed and no internal action related to the complaint was found during the review.The customer complaint was confirmed, but the condition could not be replicated.The root cause of the foreign material trapped under the electrode and corrosion cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures.It could be related to the handling of the device during the procedure or the corrosion; however, this cannot be conclusively determined.This issue was highly detectable by the physician.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 procedure with a thermocool® smart touch¿ electrophysiology catheter and the biosense webster, inc.Product analysis lab observed foreign material under an electrode.Initially it was reported that there was a current leakage error displayed on the carto 3 system.The restart of patient interface unit did not help.It was clarified that the current leakage error did not display due to a signal issue.The connection cable to catheter was replaced and it did not resolve the issue.The catheter was replaced.The new catheter worked properly.There was no patient consequence reported.The current leakage error was assessed as not mdr reportable.The issue was highly detectable and requires adjusting system components to continue with the procedure.Devices may require reset or replacing but cannot be used on the patient.Patient safety was unaffected by this issue.The biosense webster, inc.Product analysis lab received the device for evaluation and observed on 11/2/2020 foreign material was trapped under an electrode and there was corrosion on the connector.The lab finding of the foreign material was assessed as mdr reportable.The awareness date is 11/2/2020.The corrosion on the connector issue was assessed as not mdr reportable.The risk to the patient was low.

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) during an internal review on 12/1/2020, it was noted that there was a correction to the 3500a initial as the "h6.Medical device problem code" of "contamination/decontamination problem" was omitted in error.Therefore, this field has been processed.

• 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: 10916788
• MDR Text Key: 219369756
• Report Number: 2029046-2020-01820
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009002
• UDI-Public: 10846835009002
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2021
• Device Model Number: D133602
• Device Catalogue Number: D133602
• Device Lot Number: 30329859M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2020
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; UNKNOWN BRAND CABLE; UNKNOWN BRAND CABLE; UNKNOWN BRAND CATHETER