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

Model Number D134805

Device Problem Entrapment of Device (1212)

Patient Problem Mitral Insufficiency (1963)

Event Date 12/18/2019

Event Type  Injury  

Manufacturer Narrative

The product has not been returned for analysis.However, a picture was provided by the customer.The photo investigation completed (b)(6) 2019.According to pictures provided by customer, tissue residues were observed on the catheter distal tip and reddish material was inside clear pebax.A manufacturing record evaluation was performed and no internal actions were identified.Customer complaint regarding the biological material was confirmed.The root cause of the adverse event remains unknown.However, the device has not been returned for analysis.If the device is received in the future, the product analysis will be performed as appropriate in order to determine the root cause of complaint.Manufacture reference no: (b)(4).

Event Description

It was reported that a (b)(6) female patient underwent an ablation procedure for atrial fibrillation (afib) with thermocool smart touch sf bi-directional navigation catheter, and device entrapment and mitral valve incompetence issues occurred.During the case, the stsf catheter got caught in the chordae and left ventricle.There was difficulty removing the catheter.It was removed by giving it slight rotations.No physical damage was observed.When the catheter was pulled out there was tissue stuck on the tip of the catheter.The case had to be aborted and the medical intervention provided to the patient was transthoracic echocardiography (tte).It was reported that the patient went from mild to severe mitral regurgitation (mr).No medical/surgical intervention was required.Patient condition improved and was reported in stable condition.Post-procedural transthoracic echocardiograms (tte) and transesophageal echocardiograms (tee) exams demonstrated mild to moderate mitral regurgitation.Physician¿s opinion regarding the cause of the event is that it was bwi product malfunction and procedure related.It was also reported that when connecting the ultrasound catheter to the system, the whole system crashed.The study was re-opened and resumed but when the catheter was connected the issue remained.The ablation catheter was then unplugged, and the issue persisted.Additionally, it was also reported the cable on the smartablate foot pedal has exposed wires.

Manufacturer Narrative

It was reported that a 60 year old female patient underwent an ablation procedure for atrial fibrillation (afib) with thermocool® smart touch® sf bi-directional navigation catheter, and device entrapment and mitral valve incompetence issues occurred.On (b)(6)2020 , additional information was received from the biosense webster inc.(bwi) representative indicating that the physician was using the catheter in a retrograde manner through the aortic valve.The catheter was facing inferiorly.The physician attempted to deflect toward the valve, but the catheter would not move.There was a high force reading on the catheter at the time.With manipulation using clockwise torque and a pull on the catheter.The catheter ¿jumped¿ out of its position and was withdrawn out of the body.It was noted that tissue was present on the tip of the catheter.There were no physical defects on the catheter noted at that time.When bwi representative was discussing with the physician, there was concern that maybe a product malfunction could have resulted in the event.However, there was no direct evidence for this.The additionally provided information of observed high force has been assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury is remote.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (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: 9590943
• MDR Text Key: 189008599
• Report Number: 2029046-2020-00078
• 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: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2020
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30283846M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SMARTABLATE GENERATOR KIT-US
• Patient Age: 60 YR