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

Model Number D134804

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

Patient Problems Perforation of Vessels (2135); No Code Available (3191)

Event Date 02/27/2020

Event Type  Injury  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

Event Description

It was reported that a patient underwent atrial fibrillation (afib) ablation procedure with thermocool® smart touch® sf bi-directional navigation catheter and suffered vessel perforation requiring surgical intervention.During the mapping of premature ventricular contraction with retrograde approach the tip of the thermocool® smart touch® sf bi-directional navigation catheter became bent.While removing the catheter from the patient, to exchange for a new catheter, the catheter curve dissected the right common iliac artery.Vascular surgery came and placed two covered stents in the right common iliac artery.The patient remained stable.The patient is stable and in recovery.The case was aborted.The carto 3 system is working per specifiication.The thermocool® smart touch® sf bi-directional navigation catheter has been determined to be the root cause of the complaint.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The customer¿s reported bent catheter is not considered to be an mdr reportable issue since the potential that bent tip could cause or contribute to a death or serious injury, or other significant adverse event, is remote.However, since the event resulted in an adverse event which required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, this event has been assessed as mdr reportable.

Manufacturer Narrative

It was reported that a patient underwent atrial fibrillation (afib) ablation procedure with thermocool® smart touch® sf bi-directional navigation catheter and suffered vessel perforation requiring surgical intervention.During the mapping of premature ventricular contraction with retrograde approach the tip of the thermocool® smart touch® sf bi-directional navigation catheter became bent.While removing the catheter from the patient, to exchange for a new catheter, the catheter curve dissected the right common iliac artery.Vascular surgery came and placed two covered stents in the right common iliac artery.The patient remained stable.The patient is stable and in recovery.The case was aborted.The carto 3 system is working per specifiication.The thermocool® smart touch® sf bi-directional navigation catheter has been determined to be the root cause of the complaint.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Device investigation details: the device investigation has been completed which included a manufacturing record evaluation (mre).The manufacturing record evaluation (mre) was performed for the finished device 30300206m number, and no internal action was found during the review.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: 9870671
• MDR Text Key: 191695295
• Report Number: 2029046-2020-00455
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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: 02/27/2020

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: 10/08/2020
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30300206M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/27/2020
• Initial Date FDA Received: 03/23/2020
• Supplement Dates Manufacturer Received: 04/24/2020
• Supplement Dates FDA Received: 04/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM
• Patient Outcome(s): Life Threatening; Required Intervention