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

Catalog Number D132705

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

Patient Problem Perforation of Vessels (2135)

Event Date 02/08/2019

Event Type  Injury  

Manufacturer Narrative

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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.A manufacturing record evaluation was performed for the finished device 30104127m number, and no internal action was found during the review.Concomitant product: non biosense webster, inc.- st.Jude medical sheath.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and suffered vessel perforation.During the procedure, while the thermocool® smart touch¿ bi-directional navigation catheter and the st.Jude medical sheath were placed retrograde in the iliac artery, the catheter was difficult to advance.Contrast injection revealed that the artery was tortuous.The physician continued to advance the catheter trying to reach the left ventricle; however, it was unable to reach the aortic arch.The thermocool® smart touch¿ bi-directional navigation catheter was removed from the patient¿s body, and possibly the sheath was moved in this process.An interventionist was called and could not determine where the sheath was located.A perforation to the iliac artery occurred.It is unknown at the time if the patient was sent to surgery.No further information is known regarding the patient status.There is no information about the hospitalization.No ablation was performed during the case.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

Manufacturer Narrative

The biosense webster inc.Product analysis lab received the device for evaluation on (b)(6)2019.Therefore, populated d10.Device available for evaluation?, d10.Is device returned to manufacturer? and d10.Date device returned to manufacturer.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.No: pc-000387749.

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and suffered vessel perforation.During the procedure, while the thermocool® smart touch¿ bi-directional navigation catheter and the st.Jude medical sheath were placed retrograde in the iliac artery, the catheter was difficult to advance.Contrast injection revealed that the artery was tortuous.The physician continued to advance the catheter trying to reach the left ventricle; however, it was unable to reach the aortic arch.The thermocool® smart touch¿ bi-directional navigation catheter was removed from the patient¿s body, and possibly the sheath was moved in this process.An interventionist was called and could not determine where the sheath was located.A perforation to the iliac artery occurred.It is unknown at the time if the patient was sent to surgery.No further information is known regarding the patient status.There is no information about the hospitalization.No ablation was performed during the case.The device was visually inspected and it was found in good conditions.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.Then, 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 tests were performed and it was found within specifications.The catheter was irrigating and deflecting correctly.Then, the catheter outer diameter was measured and it was found within specification.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¿ 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: 8376024
• MDR Text Key: 137373199
• Report Number: 2029046-2019-02736
• 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
• Report Date: 02/08/2019

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: 09/05/2019
• Device Catalogue Number: D132705
• Device Lot Number: 30104127M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Initial Date Manufacturer Received: 02/08/2019
• Initial Date FDA Received: 02/27/2019
• Supplement Dates Manufacturer Received: 08/02/2019; 08/23/2019
• Supplement Dates FDA Received: 08/02/2019; 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE SECTION H10
• Patient Outcome(s): Life Threatening