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

Model Number D134805

Device Problem Pacing Problem (1439)

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

Event Date 02/25/2021

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 an unknown ablation procedure with a thermocool¿ smart touch¿ sf bi-directional navigation catheter (stsf) where an unwanted pacing issue occurred.When the stsf was connected to the piu, pacing port was opened.The cable was replaced but the issue continued.The issue was resolved by changing the smart touch sf catheter with another one.The pacing leads were connected to the piu primary pacing port and the carto did not allow pacing and ablating at the same time.The procedure was completed without patient consequence.With the information available, this issue was assessed as a mdr reportable unwanted pacing issue.

Manufacturer Narrative

On (b)(6) 2021, biosense webster inc.Received additional information indicating that the pacing stimulator used during the procedure was a sec5104, nihon kohden corporation brand/model stimulator.The response to the question of whether it was a planned or emergency pacing was: ¿not going to do pacing.It was a trouble that the selection of the pacing port was made at random when the catheter was connected.¿ on (b)(6) 2021, additional information was received confirming that there was no unwanted pacing being delivered.As such, this event will no longer be considered an unwanted pacing issue and no longer considered to be a mdr reportable event.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: 11548505
• MDR Text Key: 266252658
• Report Number: 2029046-2021-00389
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30445432M
• Date Manufacturer Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PACING STIMULATOR SEC5104, NIHON KOHDEN CORP; UNKNOWN BRAND CABLE; UNK_CARTO 3; UNK_SMART TOUCH BIDIRECTIONAL SF