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

Model Number D134701

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

Patient Problems Cardiac Tamponade (2226); No Code Available (3191)

Event Date 10/05/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6)."no code available" is being used to represent the surgical intervention.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).

Event Description

It was reported that a male patient underwent cardiac ablation procedure for premature ventricular contraction (pvc) with thermocool® smart touch® sf uni-directional navigation catheter and suffered cardiac tamponade requiring surgical intervention.During ablation in the right ventricular outflow tract (rvot), just below the pulmonary valve, a steam pop occurred and a blood pressure drop was noticed.Pericardiocentesis was performed but the bleeding would not stop so percutaneous cardiopulmonary support (pcps) was implanted and the patient was transferred to thoracotomy.Blood pressure was stable after the case, and prognosis was followed up on in the ward.The physician¿s commented that this event is likely to be due to ablation: the physician¿s opinion is that the cause of the event is the procedure.The patient fully recovered.No extended hospital stay was required.Steam pop is not an mdr-reportable issue.Since cardiac tamponade may be life threatening, this event is mdr reportable.

Manufacturer Narrative

On 11/25/2020, the product investigation was completed.It was reported that a male patient underwent cardiac ablation procedure for premature ventricular contraction (pvc) with thermocool® smart touch® sf uni-directional navigation catheter and suffered cardiac tamponade requiring surgical intervention.During ablation in the right ventricular outflow tract (rvot), just below the pulmonary valve, a steam pop occurred and a blood pressure drop was noticed.Pericardiocentesis was performed but the bleeding would not stop so percutaneous cardiopulmonary support (pcps) was implanted and the patient was transferred to thoracotomy.Blood pressure was stable after the case, and prognosis was followed up on in the ward.The physician¿s commented that this event is likely to be due to ablation: the physician¿s opinion is that the cause of the event is the procedure.The patient fully recovered.No extended hospital stay was required.Device evaluation details: the device was visually inspected and it was found in good conditions.The magnetic, temperature and force features were tested and no issues were observed.In addition, the catheter was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device 30360561l number, and no internal action was found during the review.The catheter passed all the specifications.The root cause of the adverse event remains unknown.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.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 UNI-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: 10757126
• MDR Text Key: 213866491
• Report Number: 2029046-2020-01574
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: 10846835009774
• 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
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2021
• Device Model Number: D134701
• Device Catalogue Number: D134701
• Device Lot Number: 30360561L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Date Manufacturer Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; CARTO3 EXTERNAL REFPATCH 6PACK; SMARTABLATE IRR TUBE SET; SOUNDSTAR ECO CATHETER
• Patient Outcome(s): Life Threatening; Required Intervention