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

Model Number D134801

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2020

Event Type  malfunction  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(6).Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a blood clot issue occurred.It was reported that during mitral isthmus ablation (6 hours into the use of the thermocool® smart touch® sf bi-directional navigation catheter) the impedance value rose rapidly.When the thermocool® smart touch® sf bi-directional navigation catheter was removed from the patient¿s body, there was blood clot.The procedure was completed at that point.There was no patient consequence.Since the formation on the catheter was not clearly differentiated from char and it formed after 6 hours of ablation, a strong argument can be made that it was char.However, the issue of a blood clot on the device is considered to be an mdr reportable malfunction.The high impedance issue is not mdr reportable since the potential that it can cause or contribute to serious injury is remote.

Manufacturer Narrative

On 7/13/2020, the biosense webster inc.Product analysis lab received the complaint device.On 7/14/2020, the product investigation was completed.It was reported that a patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a blood clot issue occurred.It was reported that during mitral isthmus ablation (6 hours into the use of the thermocool® smart touch® sf bi-directional navigation catheter) the impedance value rose rapidly.When the thermocool® smart touch® sf bi-directional navigation catheter was removed from the patient¿s body, there was blood clot.The procedure was completed at that point.There was no patient consequence.Device evaluation details: the device was visually inspected, and it was found in good normal conditions, no was found blood clot on the tip, it could be remover during decontamination process.Electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.Additionally, the catheter was tested on the generator and the temperature and impedance values were observed within specifications.Then, a cool flow pump test was performed, and it was found within specifications, the catheter was irrigating correctly, no irrigation issues were observed.A manufacturing record evaluation was performed for the finished device 30335342m number, and no internal actions to the reported complaint condition were identified.The customer complaint cannot be confirmed since the device was found working correctly and no evidence of blood clot residues were observed on the catheter.The root cause of the blood clot reported by the customer could be related to the usage of the device during the procedure, however, this cannot be conclusively determined.The catheter passed specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On (b)(6)2020, biosense webster inc.Received additional information indicating a smartablate generator was used during the event.This device has been added to the d11.Concomitant med.Product section.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.#(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: 10256083
• MDR Text Key: 202109386
• Report Number: 2029046-2020-00841
• 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: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2021
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30335342M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/10/2020
• Initial Date FDA Received: 07/09/2020
• Supplement Dates Manufacturer Received: 07/13/2020; 08/25/2020
• Supplement Dates FDA Received: 07/29/2020; 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK_SMARTABLATE GENERATOR.