MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number D133604IL

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/15/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).The biosense webster, inc.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.(b)(4).

Event Description

It was reported that a patient underwent a supraventricular tachycardia procedure with a thermocool® smart touch¿ electrophysiology catheter and a signal loss on all ecg's issue occurred.Initially, it was reported that during the procedure, an error code '7' was displayed.Another catheter was used to complete the procedure.There was no patient consequence reported.This error code displayed was assessed as not mdr reportable.This issue is highly detectable and requires adjusting the system components to continue with the procedure.Devices may require reset or replacing but cannot be used on the patient.Patient safety is unaffected by this issue.Additional information was received on the event on april 22, 2020.The error code '7' which displayed was due to a signal loss issue.The catheter was inside the patient¿s body.The signal loss was observed on all ecg's (carto 3 system and recording system).The physician had no external source to monitor the patient during the signal loss issue.This event was originally considered non-reportable; however, biosense webster inc.Became aware of the signal loss on all ecg's issue on april 22, 2020 and have reassessed the event as mdr reportable.

Manufacturer Narrative

It was reported that a patient underwent a supraventricular tachycardia procedure with a thermocool® smart touch¿ electrophysiology catheter.It was reported that during the procedure, an error code '7' was displayed.Another catheter was used to complete the procedure.There was no patient consequence reported.Additional information was received on the event on (b)(6)2020.The error code '7' which displayed was due to a signal loss issue.The catheter was inside the patient¿s body.The signal loss was observed on all ecg's (carto 3 system and recording system).The physician had no external source to monitor the patient during the signal loss issue.A picture was provided by the customer on (b)(6)2020 and has been assessed.The picture shows the error 7 message and the ecg panel was not visible.Therefore, there was no change in reportability.The error 7 remains assessed as not mdr reportable and the signal loss issue remains assessed as mdr reportable.Investigation summary: an analysis was performed on the picture that was provided by the customer.According to the picture, error 7 was observed on carto 3 screen.The customer complaint was confirmed.The product analysis was performed as appropriate in order to find the root cause of the complaint.The device was visually inspected and it was found in good conditions.An electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.Then, magnetic sensor functionality was tested on carto and the catheter was properly visualized and no errors 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: pc-000686502.

• Brand Name: THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 10048261
• MDR Text Key: 195952441
• Report Number: 2029046-2020-00597
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• 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: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2020
• Device Catalogue Number: D133604IL
• Device Lot Number: 30273127M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2020
• Date Manufacturer Received: 05/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; UNKNOWN BRAND CATHETER; UNKNOWN BRAND RECORDING SYSTEM