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

Catalog Number D132705

Device Problems Device Contamination with Chemical or Other Material (2944); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Tamponade (2226)

Event Date 08/24/2018

Event Type  Injury  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.(b)(4).

Event Description

It was reported that a female patient underwent a right sided idiopathic ventricular tachycardia (idvt) ablation procedure with thermocool® smart touch¿ bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.During the ablation phase, after multiple rf deliveries between 15-25 watts, the patient's blood pressure had dropped.Cardiac tamponade was confirmed by intracardiac echocardiograph (ice).Remainder of the procedure was aborted.Pericardiocentesis was performed to remove 450 cc of fluid form the pericardial space.The patient immediately stabilized after pericardial puncture.Extended hospitalization was required for observation purposes.Patient¿s outcome is improved.Physician did not attribute the causality of the adverse event to a bwi product malfunction.There were no error messages observed on any bwi equipment during the procedure.Transseptal puncture was not performed.The generator was in power control mode with default cut-offs.The power titrated during the ablation, it is unknown how fast did it reach its target setting before the event.The overall ablation time for ablation and the last ablation cycle at the site of injury are unknown.The catheter irrigation was set at 17-30 ml/min.The patient received anticoagulant (unspecified) during the event with an activated clotting time (act) of 250-300 seconds.The shaft proximity interference (spi) value is unknown.The thermocool® smart touch¿ bi-directional navigation catheter was not in close proximity to another catheter.It was zeroed after the initial warm-up phase post catheter connection to the carto 3 piu.The carto 3 system did not indicate to re-zero the catheter.

Manufacturer Narrative

On (b)(6) 2018, the biosense webster inc.(bwi) failure analysis lab (fal) received the device for evaluation.Initial visual analysis found the tip of catheter appears to be occluded.Foreign material in the irrigation holes.This issue has been reviewed and assessed as mdr reportable.Upon receipt of the catheter, the lot # was verified to be 30039499m, as such field d4.Lot was populated along with d4.Expiration date of (b)(6) 2019 and manufacture date of (b)(6) 2018.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.Manufacturer¿s ref # (b)(4).

Manufacturer Narrative

On 10/16/2018, the device history record (dhr) for the lot number 30039499m was reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Manufacturer's ref # (b)(4).

Manufacturer Narrative

It was reported that a female patient underwent a right sided idiopathic ventricular tachycardia (idvt) ablation procedure with thermocool® smart touch¿ bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.On 9/19/2018, the biosense webster inc.(bwi) failure analysis lab (fal) received the device for evaluation.Initial visual analysis found the tip of catheter appears to be occluded.Foreign material in the irrigation holes.This issue has been reviewed and assessed as mdr reportable.Product evaluation details: the product evaluation has been completed.The device was inspected and foreign material was observed in the irrigation holes.The magnetic sensor was tested on carto and the catheter was properly visualized and no errors were observed.Then, the force sensor was tested and it was working properly; the force values were observed within specifications.An 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, the irrigation and deflection test were performed and it was found within specifications, the catheter was irrigating and deflecting correctly.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The catheter passed all specifications.The root cause of the adverse event remains unknown.The foreign material was lost during the analysis, it could be related to the dried saline solution use during the procedure, however, this cannot be conclusively determined.The ifu states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.Manufacturer¿s ref # (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ 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: 7890275
• MDR Text Key: 120755140
• Report Number: 2029046-2018-02075
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/24/2018

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: 04/15/2019
• Device Catalogue Number: D132705
• Device Lot Number: 30039499M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Initial Date Manufacturer Received: 08/24/2018
• Initial Date FDA Received: 09/19/2018
• Supplement Dates Manufacturer Received: 09/19/2018; 10/16/2018; 11/12/2018
• Supplement Dates FDA Received: 10/04/2018; 10/24/2018; 12/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM (CATALOG # UNK / SERIAL # (B)(4); CARTO 3 SYSTEM (CATALOG # UNK / SERIAL # UNK
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention