MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number D128211

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Air Embolism (1697); Tachycardia (2095); Ischemic Heart Disease (2493)

Event Date 09/14/2022

Event Type  Injury  

Manufacturer Narrative

Device investigation details: 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 (mre) cannot be conducted because no lot number was provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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 ref.# (b)(4).

Event Description

It was reported that a female patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter and the patient suffered electrocardiogram st segment elevation, ventricular tachycardia and a possible air embolism.After the second transeptal during an afib case and while mapping with the pentaray nav high-density mapping eco catheter catheter, there was st elevation displayed on the ekg and the patient went into ventricular tachycardia.The st elevation and the ventricular tachycardia were non-sustained and lasted about 13 seconds.The patient experienced a drop in blood pressure and the patient also has a low ejection fraction (ef).Anesthesia supported the patient¿s blood pressure and about 5-10 minutes later, the blood pressure and ejection fraction (ef) normalized.There was no pericardial effusion.They did not perform any medical intervention and the procedure was continued and completed.The patient was reported to be in stable condition.The bwi representative reported that the patient was alert and had a full range of motion in the arms and legs.The activated clotting time (act) was within guidelines and was above 300.The patient will stay overnight for observation.The physician believed that an air embolism had occurred.The physician¿s opinion on the cause of this adverse event is that it was procedure related.The patient fully recovered with no residual effects.The patient did not require extended hospitalization because of the adverse event.The patient stayed overnight due to time the procedure ended late in the day.The patient has a relevant history of atrial fibrillation (afib).A smartablate system irrigation pump was used during this procedure.When the situation occurred, md believed it was more disease state of the patient associated with the event.Md had not come to this conclusion until after the case was over and all products were disposed.The sheath used was a sl1 sheath from abbott.No ablation was not performed before event.Never did the md feel the issue was due to any bwi equipment.The pump appeared to detect bubbles consistently and functioning properly as it has throughout its use at the account.The smartablate pump was not being used with the pentaray nav high-density mapping eco catheter.The smartablate pump was connected to stsf d-f which as in a vizigo sheath.The vizigo was in the second transseptal site and not being used at the time.The pentaray nav high-density mapping eco catheter was not connected to a pump, it was connected to a pressure bag for irrigation.The pentaray nav high-density mapping eco catheter was in an abbott sl1 sheath.The doctor stated there was a new technician and it was thought that the new technician did not properly flush the pentaray nav high-density mapping eco catheter and the sl1 sheath which possibly caused the event.

• Brand Name: PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15594152
• MDR Text Key: 301630989
• Report Number: 2029046-2022-02507
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2022
• 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: ABBOTT SL1 SHEATH; SMARTABLATE PUMP KIT-US; UNK_CARTO VIZIGO SHEATH; UNK_SMART TOUCH UNIDIRECTIONAL
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Female