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

Model Number D134804

Device Problems Failure to Sense (1559); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Air Embolism (1697); Non specific EKG/ECG Changes (1817); ST Segment Elevation (2059)

Event Date 10/02/2020

Event Type  Injury  

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 female patient ((b)(6) 89kg) underwent cardiac ablation procedure for atrioventricular nodal reentrant tachycardia (avnrt)/wolff-parkinson-white (wpw) syndrome with a thermocool® smart touch® sf bi-directional navigation catheter and suffered st-segment elevation requiring no intervention.The patient had previous ablation performed in (b)(6) 2020 by another physician, and she came back for a recurrent supraventricular tachycardia (svt) which could not be reproduced on high dose isuprel or adenosine.During the procedure there was a 105 magnetic sensor error on the carto.The catheter cable was replaced, and the issue did not resolve.The catheter was replaced and that issue resolved, but the patient began having st-segment elevation.The physician reported that air must have been introduced through the sheath or the catheter.The st-segment elevation lasted approximately seven minutes and resolved on its own without intervention.The ablation catheter was the only biosense webster product in the body.This event was noted during the use of our products while changing out to the new ablation catheter.The physician¿s opinion is that the cause of this event was biosense webster (bwi) product malfunction.They believe that the adverse event occurred because of the bwi product malfunction and the need to switch out to a new ablator once the transseptal puncture was completed.Patient did not require any surgical intervention and the st levels stabilized on their own.Patient fully recovered.It was not confirmed whether the patient required extended hospitalization due to this procedure.The magnetic sensor error is not an mdr-reportable issue.The electrocardiogram st segment elevation is an mdr-reportable issue.Air embolism is an mdr-reportable issue.

Manufacturer Narrative

On 12/2/2020, the product investigation was completed as the complaint device was not returned.It was reported that a female patient (35 year old, 89kg) underwent cardiac ablation procedure for atrioventricular nodal reentrant tachycardia (avnrt)/wolff-parkinson-white (wpw) syndrome with a thermocool® smart touch® sf bi-directional navigation catheter and suffered st-segment elevation requiring no intervention.The patient had previous ablation performed in 03/2020 by another physician, and she came back for a recurrent supraventricular tachycardia (svt) which could not be reproduced on high dose isuprel or adenosine.During the procedure there was a 105 magnetic sensor error on the carto.The catheter cable was replaced, and the issue did not resolve.The catheter was replaced and that issue resolved, but the patient began having st-segment elevation.The physician reported that air must have been introduced through the sheath or the catheter.The st-segment elevation lasted approximately seven minutes and resolved on its own without intervention.The ablation catheter was the only biosense webster product in the body.Device investigation details: since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.However, a manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.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: 10742730
• MDR Text Key: 214387409
• Report Number: 2029046-2020-01572
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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
• Type of Report: Initial,Followup
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/05/2021
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30416506M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/02/2020
• Initial Date FDA Received: 10/27/2020
• Supplement Dates Manufacturer Received: 12/02/2020
• Supplement Dates FDA Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; SMARTABLATE GENERATOR; SMARTABLATE PUMP; UNKNOWN SHEATH; UNK_TRANSEPTAL NEEDLE; UNSPECIFIED CATHETER CABLE
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 35 YR
• Patient Weight: 89