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

Model Number D132705

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pericardial Effusion (3271)

Event Date 12/08/2020

Event Type  Injury  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 cardiac ablation procedure for premature ventricular contraction (pvc) with thermocool® smart touch® bi-directional navigation catheter and suffered cardiac perforation requiring no intervention.The physician wanted to enter the coronary sinus (cs) with thermocool® smart touch® bi-directional navigation catheter.They ablated the pvc at the right spot but after the ablation they realized that the thermocool® smart touch® bi-directional navigation catheter was in the pericardial space (based on to a cs snapshot taken previously with another catheter).They probably entered the pericardial space by pushing too much with the thermocool® smart touch® bi-directional navigation catheter at the cs ostium or in the lower posterior right atrium.The patient was stable the whole time.They saw a very small pericardial effusion on echo.They managed to pull out the catheter and the sheath without any other complication (no tamponade).There was no report of extended hospitalization.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Since this event may be life threatening; might result in permanent impairment of a body function or permanent damage to a body structure; or required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure it is mdr-reportable.

Manufacturer Narrative

On (b)(6) 2021, additional information was received regarding the event, which includes the following: the patient's gender, confirmation of required intervention, confirmation of prolonged hospitalization, transseptal puncture, visitag parameters, updated event coding, and concomitant products used.It was reported that a male patient underwent cardiac ablation procedure for premature ventricular contraction (pvc) with thermocool® smart touch® bi-directional navigation catheter and suffered cardiac perforation requiring no intervention but prolonged hospitalization.The physician wanted to enter the coronary sinus (cs) with thermocool® smart touch® bi-directional navigation catheter.They ablated the pvc at the right spot but after the ablation they realized that the thermocool® smart touch® bi-directional navigation catheter was in the pericardial space (based on to a cs snapshot taken previously with another catheter).They probably entered the pericardial space by pushing too much with the thermocool® smart touch® bi-directional navigation catheter at the cs ostium or in the lower posterior right atrium.The patient was stable the whole time.They saw a very small pericardial effusion on echo.They did a computerized tomography (ct) scan (with catheter in the heart) and they put the patient in surgery room to remove the catheter in case they had to do a thoracotomy.In the end, they did not need to do a thoracotomy.They managed to pull out the catheter and the sheath without any other complication (no tamponade).Prolonged hospitalization was required to ensure the patient did not develop pericardial effusion.Transseptal puncture was done with an abbot sl0 needle.There was no evidence of steam pop during the ablation.Visitag stability parameters were 3mm, 3s, 25%, 3gr, size 3.Ablation index was used as coloring option.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 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: 11101542
• MDR Text Key: 224588799
• Report Number: 2029046-2020-02037
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

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: 10/01/2021
• Device Model Number: D132705
• Device Catalogue Number: D132705
• Device Lot Number: 30448867M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/31/2020
• Supplement Dates Manufacturer Received: 01/04/2021
• Supplement Dates FDA Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0056-2018
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention