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

Model Number D134804

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Ventricular Fibrillation (2130)

Event Date 08/18/2021

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.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.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 female patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered ventricular fibrillation.During an atrial fibrillation procedure, it was noticed that the patient went into ventricular fibrillation (vf).After creating geometry in the right atrium with the pentaray catheter, the physician then placed the catheter on the lateral side of the isthmus.When they started to pace the coronary sinus to look for isthmus block, the patient went into vf.It was noticed that the patient went into vf via the signals displayed on the carto 3 system.Medical intervention provided to the patient was defibrillation.The patient was restored back to normal sinus rhythm.Then when doing an activation map of the lateral side, the patient went into vf again, which was noticed via the signals on the carto 3 system.The patient was defibrillated once again, and the patient was restored to normal sinus rhythm.The patient was reported to be in stable condition.The physician does not believe the carto 3 system or any of the bwi catheters in use, were the cause of the issue.The patient already had a "bi-v icd" implanted (biventricular defibrillator) prior to the procedure.The physician¿s opinion regarding the cause of this adverse event is that this patient condition related.The patient fully recovered with no residual effects and no extended hospitalization was required.The pacing leads were connected to the carto primary pacing port.The pacing stimulator was a micropace.There was no unwanted pacing being delivered.Ablation was performed.

• 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 ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12457473
• MDR Text Key: 272876545
• Report Number: 2029046-2021-01530
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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
• Report Date: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2021
• 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): Life Threatening; Required Intervention