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)

Event Date 10/17/2022

Event Type  Injury  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc.Or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 60-year-old male patient (212 lbs) underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient experienced st segment elevation requiring intervention and ventricular tachycardia causing case to be cancelled.It was reported that during an afib case, the patient was discovered to have severe st elevation.Bwi representative reported the st elevation was confirmed on the body surface electrocardiogram (ekg).It was also reported that an interventionalist was called for medical intervention and shot contrast into the right and left coronary sinus.The right coronary had an area that was thinner which caused the st elevation.There was spontaneous vt coming from the right ventricle.It was confirmed that the case was canceled.The patient was reported to be in stable condition.The catheters in the body at the time were: soundstar catheter, stsf catheter, vizigo sheath, octaray catheter, and webster cs catheter.The physician suspects that this was due to an undiscovered issue on the patient or may have been due to isuprel.The physician¿s opinion on the cause of this adverse event is that it was due to patient condition.Contrast was shot into the coronaries as intervention.The patient outcome of the adverse event is fully recovered (no residual effects).The patient did not require extended hospitalization because of the adverse event.A smart ablate generator was used (g4c-2026 ref: m490002).The catheter and its package were disposed of in a biohazard waste.It is life threatening; it might result in permanent impairment of a body function or permanent damage to a body structure; or it required medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure.

• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15786243
• MDR Text Key: 303564397
• Report Number: 2029046-2022-02810
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2022
• 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?: Yes
• Date Manufacturer Received: 10/17/2022
• 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
• Treatment: OCTARAY CATHETER; SMARTABLATE GENERATOR; SOUNDSTAR CATHETER; VIZIGO SHEATH; WEBSTER CS CATHETER
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 96 KG