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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hematoma (1884); Vascular Dissection (3160)

Event Date 06/16/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).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 atrial tachycardia procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered a vascular dissection and hematoma requiring percutaneous transluminal angioplasty (pta).During the stage before catheter insertion, hematoma occurred due to injury of the small branch of the right inguinal femoral artery.The thin branch of the femoral artery was touched with a competitor's sheath or wire, resulting in hematoma in the right inguinal femoral artery.Hemostasis was completed by pressure from the puncture site, but the patient was shifted to pta.However, since hematoma developed, the procedure was discontinued.After completing the pta and packing it with a coil, patient went to the ward safely.The treatment course was favorable, and the patient was doing well.Since the blood vessels of a and v may be connected, it was judged that operation may be necessary in the future.Injury to the right inguinal femoral branch was prior to insertion of the biosense product into the heart.No further information is available.Should more information become available, it will be reviewed and processed accordingly.

Manufacturer Narrative

During an internal review by the biosense webster inc.(bwi) medical safety officer, it has been determined that this event is related to access and that the bwi product is considered concomitant.Injury to the right inguinal femoral branch was prior to insertion of the bwi product into the heart.Therefore, this event will no longer be considered mdr reportable against any biosense webster inc.Devices.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; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12164440
• MDR Text Key: 261456755
• Report Number: 2029046-2021-01116
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NON-BWI UNKNOWN SHEATH.; SOUNDSTAR ECO SMS 8F CATHETER.; NON-BWI UNKNOWN SHEATH; SOUNDSTAR ECO SMS 8F CATHETER
• Patient Outcome(s): Life Threatening; Required Intervention