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 Tachycardia (2095); Ischemic Heart Disease (2493); Vascular Dissection (3160)

Event Date 02/28/2022

Event Type  Injury  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered tachycardia, st elevation, and vascular dissection requiring surgical intervention.It was reported that they noticed st elevations about five minutes after ablating, during the procedure, and during the waiting period.The patient was stable at first but became unstable.The patient went into tachycardia and their blood pressure dropped.An interventional cardiologist was called, and a coronary angiogram was done.The angiogram showed the patient had a dissected left main.Balloon angioplasty was done and an ecmo (extracorporeal membrane oxygenation) was placed.The patient was then transferred to the operating room for surgery.The patient was unstable when they were transferred to the operating room.No further information about the patient is available at the time of the call.The physician does not think that any of the bwi products were at fault.The maximum wattage used was 40 watts.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require 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.

Manufacturer Narrative

Additional information was received on 11-apr- 2022.It was reported that the patient is a 38-year-old, female.Therefore, the a 2.Patient age at the time of event, a 2.Age unit, a 3.Gender have been updated.It was also reported that the physician¿s opinion on the cause of this adverse event is that the catheter slipped into the left main and dissected the artery.The patient is not doing well, still in icu waiting for a heart transplant.Based on this information, the h 6.Health effect - impact code has been updated.The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (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
• 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: 13934687
• MDR Text Key: 292164517
• Report Number: 2029046-2022-00647
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/10/2022

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 Model Number: D134805
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/28/2022
• Initial Date FDA Received: 03/28/2022
• Supplement Dates Manufacturer Received: 04/11/2022
• Supplement Dates FDA Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 38 YR
• Patient Sex: Female