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

Model Number D134702

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Stenosis (2263); Ischemic Heart Disease (2493)

Event Date 01/18/2022

Event Type  Injury  

Manufacturer Narrative

The product investigation was completed as the complaint device was not returned.The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device (b)(4) number, and no internal action related to the complaint was found during the review.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 male patient underwent a premature ventricular contraction (pvc) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter.The patient suffered st elevations requiring intervention and prolonged hospitalization.The patient underwent a pvc-ablation from lv summit.For this, maps were created with carto3 and pentaray in rvot, lvot and cs.The earliest activation was seen in the lat-maps from distal cs.The plan was to ablate bipolar from cs to lvot with the osypka hat 500.To realize that strategy a celsius thermocool was placed in the lvot.After the placement of the celsius catheter via an abbott agilis sheath via the aorta, an increased st segment in bs ecg v1-v2 was seen.A cardiologist was consulted, and a coronary angiography of the right coronary artery was done.No hint of a damage was seen.So after a 10 minute waiting period, the procedure was forwarded.A uni polar ablation with tcstsf was done from cs and lvot to eliminate the pvc.That results in a 30 minute waiting period without any observed pvc.But the bs ecg shows signs of a lack of circulation in the left coronary artery system.A coronary angiography was done from the left side.A coronary artery need to treated with a drug eluted stent.This was done timely with success.The conditions of the patient where stable and the patient was transferred to the intensive care unit.The patient was reported as improved.The physician¿s opinion on the cause of this adverse event: procedure.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure and it required medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13477540
• MDR Text Key: 285355668
• Report Number: 2029046-2022-00247
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: 10846835009781
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/07/2022

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: 11/21/2022
• Device Model Number: D134702
• Device Catalogue Number: D134702
• Device Lot Number: 30663310L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/20/2022
• Initial Date FDA Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ABBOTT AGILIS SHEATH; CARTO 3 SYSTEM; CELSIUS THERMOCOOL; OSYPKA HAT500 GENERATOR; PENTARAY NAV ECO
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Male