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

Model Number D134801

Device Problem Pacing Problem (1439)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).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 cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter where an unwanted pacing issue occurred.During ablation, the pacing waveform was detected from the 3rd pole of thermocool® smart touch® sf bi-directional navigation catheter (the pacing mark was also on the 3rd pole on the catheter display on carto3).The cable was changed but the issue continued.Lab operators also do not perform pacing.The procedure was conducted as is.There was no patient consequence reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The issue was assessed as a mdr reportable unwanted pacing issue.

Manufacturer Narrative

The device evaluation was completed on 10/24/2020.It was reported that a patient underwent cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter where an unwanted pacing issue occurred.During ablation, the pacing waveform was detected from the 3rd pole of thermocool® smart touch® sf bi-directional navigation catheter (the pacing mark was also on the 3rd pole on the catheter display on carto3).The cable was changed but the issue continued.Lab operators also do not perform pacing.The procedure was conducted as is.There was no patient consequence reported.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.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.The customer complaint cannot be confirmed.The catheter passed specification.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: 10660151
• MDR Text Key: 242914730
• Report Number: 2029046-2020-01464
• 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
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2020
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30320562M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Date Manufacturer Received: 10/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; UNKNOWN BRAND CABLE