MAUDE Adverse Event Report: BIOSENSE WEBSTER INC QDOT MICRO; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Catalog Number D139505

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Air Embolism (1697); Stroke/CVA (1770); Embolism/Embolus (4438)

Event Date 12/05/2023

Event Type  Injury  

Event Description

It was reported a patient underwent a cardiac ablation procedure with a qdot micro and patient experienced a stroke.The procedure preparation was done by the nurses as usual.The procedure was performed as usual.During procedure, 1 bubble alert of the ngen pump occurred.Infusion set was flushed and cleared free of bubbles.Procedure was continued and finished as usual.No consequences for patient when leaving the room.Patient experienced a stroke.Mri showed lots of embolism in the capillaries of the brain.Transesophageal echocardiogram (tee) from the day of the procedure was checked.No thrombus in the laa and no evidence of char, thrombus or clot during the procedure.Physician thinks it may be several microbubble embolism.Additional information was received.Symptoms started after procedure.Event was discovered one day after.The patient was still in neurological rehabilitation.Patient outcome was improved.Physician's opinion on cause was the procedure.

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).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.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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Additional information received on 24-jan-2024.It was diagnostically confirmed the detected embolisms were multiple small air bubbles.The patient could recuperate about 50%.Act levels recorded during procedure: 239sec -> 10000 heparin, 269sec -> 5000 heparin, 372sec -> 5000 heparin.Due to the additional information received confirming diagnostically that the embolisms were air, the assessment was made to update the h6.Health effect - clinical code from embolism/embolus (e0503) to air embolism (e050301).In addition, since this event is now coded as air embolism, the assessment was made to also report this event under the ngen pump, eu configuration.The mdr reportable assessment awareness date for the ngen pump, eu configuration is 24-jan-2024.Therefore, biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2024-00045 for product code d139505 (qdot micro) (2) mfr # 2029046-2024-00369 for product code d139701 (ngen pump, eu configuration) if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.During an internal review on 31-jan-2024, noted a correction to the 3500a initial as inadvertently omitted the concomitant products.Therefore, processed ¿d10.Concomitant medical products and therapy dates¿ field.

Manufacturer Narrative

Additional information was received on 16-apr-2024.Catheter was inside the patient when flushing was performed, but the stopcock valve was closed to the catheter.No ablation was performed during flushing.The tubing set product information was unknown.Therefore, added the unk tubing set to the d10.Concomitant medical products and therapy dates section.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: QDOT MICRO
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• 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: 18440997
• MDR Text Key: 331864437
• Report Number: 2029046-2024-00045
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835016758
• UDI-Public: 10846835016758
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P210027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D139505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2024
• 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: 7FR DECAN,11P,D,2.4MMLE,282MM,; 8.5F SHEATH WITH CURVE VIZ MDC; NGEN PUMP, EU CONFIGURATION; NGEN RF GENERATOR; PENTARAY NAV ECO 7FR, F, 2-6-2; PREF.GUIDING SHEATH W/MULT.CRV; UNK TUBING SET; UNK_CARTO 3
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 83 YR
• Patient Sex: Female