MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NGEN PUMP, EU CONFIGURATION; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D139701

Device Problem Patient Device Interaction Problem (4001)

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

Event Date 12/05/2023

Event Type  Injury  

Manufacturer Narrative

The hardware investigation has begun but it has not been 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 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.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).

Event Description

Initially, the adverse event was assessed as mdr reportable under the qdot micro catheter reported under manufacturer report number 2029046-2024-00045.Additional information was received on 24-jan-2024 confirming diagnostically that the embolisms were air.Therefore, the assessment was made to update the h6.Health effect - clinical code from embolism/embolus (e0503) to air embolism (e050301) and to also report this event under the ngen pump, eu configuration.The awareness date for the ngen pump, eu configuration report is 24-jan-2024.It was reported a patient underwent a cardiac ablation procedure with a qdot micro and ngen pump, eu configuration 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, eu configuration 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 on 19-dec-2023.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.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.

Manufacturer Narrative

It was reported a patient underwent a cardiac ablation procedure with a qdot micro and ngen pump, eu configuration.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, eu configuration 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.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.The investigation was completed on (b)(6) 2024.The service was declined.No further investigation was performed, as it was not initially required.A device history record evaluation was performed for the finished device number, and no internal actions related to the reported complaint condition were identified.All devices are manufactured, inspected, and released to approved specifications as part of biosense webster's quality process.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

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: NGEN PUMP, EU CONFIGURATION
• 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.; 560 cottonwood drive; milpitas CA
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18620169
• MDR Text Key: 334258233
• Report Number: 2029046-2024-00369
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P990071/S037
• 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: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D139701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 7FR DECAN,11P,D,2.4MMLE,282MM,; 8.5F SHEATH WITH CURVE VIZ MDC; NGEN RF GENERATOR; PENTARAY NAV ECO 7FR, F, 2-6-2; PREF.GUIDING SHEATH W/MULT.CRV; QDOT MICRO, BI, TC, D-F; UNK TUBING SET; UNK_CARTO 3
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 83 YR
• Patient Sex: Female