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

Model Number D134805

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2020

Event Type  malfunction  

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).

Event Description

It was reported that a patient underwent a right sided atrial tachycardia ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.It was reported that during a right sided atrial tachycardia ablation procedure while ablating with a thermocool® smart touch® sf bi-directional navigation catheter, it was noticed that the settings in the smartablate generator were incorrect.The ablation was done with settings for a 4mm catheter and not with smart touch sf settings.The flow was not enough, and as a result, blood clots were found adhered to the catheter.The issue was resolved by selecting the correct settings on the smartablate generator.No patient consequences were reported.The physician believed the issue was caused by a smartablate generator misconfiguration.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.There is a possibility that this issue was caused by a user error as incorrect catheter settings were selected on the smartablate generator, and the irrigation flow was not enough which might have caused thrombus formation at the tip of the catheter.However, since this cannot be confirmed, this event is being conservatively reported as thrombus/ clot under the thermocool® smart touch® sf bi-directional navigation catheter.

Manufacturer Narrative

Initially it was reported that there were blood clots adhered to the catheter.The biosense webster, inc.Product analysis lab observed on (b)(6) 2020 that the device was returned in the condition reported as there was a clot on the distal tip.This clot remains assessed as a reportable issue.The device evaluation was completed on august 7, 2020.It was reported that a patient underwent a right sided atrial tachycardia ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.It was reported that during a right sided atrial tachycardia ablation procedure while ablating with a thermocool® smart touch® sf bi-directional navigation catheter, it was noticed that the settings in the smartablate generator were incorrect.The ablation was done with settings for a 4mm catheter and not with smart touch sf settings.The flow was not enough, and as a result, blood clots were found adhered to the catheter.The issue was resolved by selecting the correct settings on the smartablate generator.No patient consequences were reported.The physician believed the issue was caused by a smartablate generator misconfiguration.The device was visually inspected and it was found with clot on the distal tip.No other damages on tip or electrodes were found.An electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.The catheter was tested on the generator and the temperature and impedance values were observed within specifications.A cool flow pump test was performed and it was found out of specifications.Then, an irrigation test was performed and the catheter did not irrigate properly in some holes.A manufacturing record evaluation (mre) was performed for the finished device, and no internal action related to the reported complaint was found during the review.The customer complaint was confirmed; however, the root cause of the clot reported by the customer could be related to the usage of the device during the procedure.However, this cannot be conclusively determined.All units are inspected prior leaving the facility and mre verified that this complaint unit was in good condition.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: pc-(b)(4).

Manufacturer Narrative

The bwi 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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Initially the device evaluation was submitted under follow-up #2.After an internal review, additional clarification to the device evaluation was needed.Below is the updated device evaluation which was completed on (b)(6), 2020.It was reported that a patient underwent a right sided atrial tachycardia ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.It was reported that during a right sided atrial tachycardia ablation procedure while ablating with a thermocool® smart touch® sf bi-directional navigation catheter, it was noticed that the settings in the smartablate generator were incorrect.The ablation was done with settings for a 4mm catheter and not with smart touch sf settings.The flow was not enough, and as a result, blood clots were found adhered to the catheter.The issue was resolved by selecting the correct settings on the smartablate generator.No patient consequences were reported.The physician believed the issue was caused by a smartablate generator misconfiguration.The device was visually inspected, and it was found with clot on distal tip, no other damages on tip or electrodes were found.Electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.The catheter was tested on the generator and the temperature and impedance values were observed within specifications.A cool flow pump test was performed, and it was found out of specifications.Then, irrigation test was performed, and the catheter did not irrigate properly in some holes.A manufacturing record evaluation was performed for the finished device, and no internal action related to the reported complaint was found during the review.The customer complaint was confirmed; however, the root cause of the holes occluded is related with the clot on tip since the catheter did not show a malfunction during the tests.The root cause of the clot reported by the customer could be related with the procedure, however this cannot be conclusively determined.All units are inspected prior leaving the facility and mre verified that this complaint unit was in good condition.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: 10347724
• MDR Text Key: 201193984
• Report Number: 2029046-2020-00980
• 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,Followup,Followup
• Report Date: 07/03/2020

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: 02/12/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30353163M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Initial Date Manufacturer Received: 07/03/2020
• Initial Date FDA Received: 07/30/2020
• Supplement Dates Manufacturer Received: 08/05/2020; 08/06/2020; 11/12/2020
• Supplement Dates FDA Received: 08/06/2020; 09/03/2020; 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SMARTABLATE GENERATOR