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

Catalog Number D134805

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation of Vessels (2135)

Event Date 10/25/2019

Event Type  Injury  

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).

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and developed vessel perforation.During the procedure, during use of the thermocool® smart touch® sf bi-directional navigation catheter and after use of the noga-star catheter, an aortic dissection was noticed.The physician was not able to gain access the second time, for retrograde arterial access.The aortic dissection was confirmed by an aortogram with dye.No medical intervention was needed.The patient was reported to be in stable condition and their condition has improved.Extended hospitalization was not required.A non biosense webster sheath was used during the procedure.The physician¿s opinion on the cause of the adverse event is procedure related and patient condition related.Since the event was discovered during use of thermocool® smart touch® sf bi-directional navigation catheter, the event will be conservatively reported under this product.

Manufacturer Narrative

Initially the patient event was only reported under the thermocool® smart touch® sf bi-directional navigation catheter and the noga-star¿ cardiology catheter was assessed as a "concomitant product".After additional review on (b)(6) 2019, since the event was discovered during use of thermocool® smart touch® sf bi-directional navigation catheter and after the use of the noga-star¿ cardiology catheter, the event will be conservatively reported under both devices.The re-assessment awareness date for the reportable determination for the noga-star¿ cardiology catheter was (b)(6) 2019.Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.In addition, on november 30, 2019, further information was provided on the event.First retrograde access was successful with noga-star¿ cardiology catheter.No needle was deployed.The physician was not able to gain access the second time with the thermocool® smart touch® sf bi-directional navigation catheter, for retrograde arterial access.The procedure was successfully completed.Patient was monitored overnight and released.Physician stated he did not think issue or complication was catheter related.Ablation was performed with thermocool® smart touch® sf bi-directional navigation catheter.Investigation summary: it was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a noga-star¿ cardiology catheter.During the procedure, during use of thermocool® smart touch® sf bi-directional navigation catheter and after use of the noga-star¿ cardiology catheter, an aortic dissection was noticed.First retrograde access was successful with the noga-star¿ cardiology catheter.No needle was deployed.The physician was not able to gain access the second time with the thermocool® smart touch® sf bi-directional navigation catheter, for retrograde arterial access.The aortic dissection was confirmed by an aortogram with dye.No medical intervention was needed.Procedure successfully completed.The patient was reported to be in stable condition and their condition has improved.Patient was monitored overnight and released.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 and no internal actions related to the reported complaint were identified.  the catheter passed all 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.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: 9348578
• MDR Text Key: 167801423
• Report Number: 2029046-2019-03902
• 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
• Type of Report: Initial,Followup
• Report Date: 10/25/2019

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: 07/25/2020
• Device Catalogue Number: D134805
• Device Lot Number: 30262322M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Initial Date Manufacturer Received: 10/25/2019
• Initial Date FDA Received: 11/20/2019
• Supplement Dates Manufacturer Received: 11/22/2019
• Supplement Dates FDA Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DEF 7F NOGA,2P,F,.5MM,HYP,FUSE; NON-BWI UNKNOWN BRAND SHEATH
• Patient Outcome(s): Life Threatening