MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OCTARAY, PERSEID, 48P, 2-2-2-2-2, D-CURVE; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number D160901

Device Problem Patient Device Interaction Problem (4001)

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

Event Date 09/13/2022

Event Type  Injury  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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 reference number: (b)(4).

Event Description

It was reported that a 57-year-old female patient underwent an atrial fibrillation (afib) ablation procedure with an octaray, perseid, 48p, 2-2-2-2-2, d-curve.The patient is in persistent afib.The patient suffered electrocardiogram st segment elevation, ventricular tachycardia, surgical intervention and possibly an air embolism.When inserting the ocataray catheter following transseptal there was an st elevation immediately noticed on the ecg.The physician then advanced the cs into the rv and began to pace.The patient went into ventricular tachycardia (vt) and was cardioverted 2 times.A stat echo and heart catheterization was performed, and the coronaries were reported to be clean, and no effusion found.The patient was stabilized by this time and the physician put in a temporary pacemaker.The patient was sent to the intensive care unit for monitoring due to low pressure with "pressors" in use while still under anesthesia.The physician thinks the event was caused by a spasm but the bwi representative suspects it was due to an air embolism as it was not verified that the octaray was ever flushed before entering the body.At the time of the event there were three biosense products inside the patient-ice catheter, vizigo and octaray.It was also reported that an ablation catheter and pentaray were opened but not used due to the adverse event.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

On 5-oct-2022, the product investigation was completed.It was reported that a 57-year-old female patient underwent an atrial fibrillation (afib) ablation procedure with an octaray, perseid, 48p, 2-2-2-2-2, d-curve.The patient is in persistent afib.The patient suffered electrocardiogram st segment elevation, ventricular tachycardia, surgical intervention and possibly an air embolism.Device evaluation details: visual analysis revealed no damage or anomalies on the device.Per the event, several tests were performed.The magnetic and electrical features were tested and no issues were observed.In addition, the product was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for finished device number 30715806l, and no internal action related to the complaint was found during the review.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.The root cause of the adverse event remains unknown.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: OCTARAY, PERSEID, 48P, 2-2-2-2-2, D-CURVE
• 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: 15526497
• MDR Text Key: 301007434
• Report Number: 2029046-2022-02375
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835021141
• UDI-Public: 10846835021141
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/01/2022

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: 01/11/2023
• Device Model Number: D160901
• Device Catalogue Number: D160901
• Device Lot Number: 30715806L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2022
• Initial Date FDA Received: 10/03/2022
• Supplement Dates Manufacturer Received: 10/05/2022
• Supplement Dates FDA Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2022
• 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: PENTARAY NAV.; THERMOCOOL SMARTTOUCH.; UNSPECIFIED TRANSSEPTAL NEEDLE.; VIZIGO SHEATH.
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female