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

Catalog Number	D139403
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	01/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Manufacturer's ref.# (b)(4).
Event or Problem Description
It was reported a patient underwent an atrial fibrillation (afib) ablation procedure with a qdot micro¿ catheter and patient experienced cardiac tamponade treated with a pericardiocentesis.It was reported by the caller that a pericardial effusion was detected.During ablation phase, the physician noticed the heart was not moving under fluoroscopy, checked the blood pressure, and a 90/50 was identified.The physician confirmed it by using intracardiac echocardiography (ice).Medical intervention provided was a pericardiocentesis, also 2 units of blood, and platelets were provided.The patient outcome is fully recovered and did not require extended hospitalization.Physician¿s opinion on the cause of this adverse event is that it was procedure related.The physician stated either perforation from difficulty accessing coronary sinus with ablation catheter or possible stacked lesions on posterior left atrial septum.Correct device settings selected on the generator and there were no error messages on equipment during the procedure.Transseptal puncture performed with baylis nrg co needle and ablation was performed.No evidence of steam pop.
Additional Manufacturer Narrative
It was reported a patient underwent an atrial fibrillation (afib) ablation procedure with a qdot micro¿ catheter and patient experienced cardiac tamponade treated with a pericardiocentesis.It was reported by the caller that a pericardial effusion was detected.During ablation phase, the physician noticed the heart was not moving under fluoroscopy, checked the blood pressure, and a 90/50 was identified.The physician confirmed it by using intracardiac echocardiography (ice).Medical intervention provided was a pericardiocentesis, also 2 units of blood, and platelets were provided.The patient outcome is fully recovered and did not require extended hospitalization.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed, and the device was recognized correctly; however, hi force appeared due to an internal printed circuit board (pcb) issue.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The root cause of the adverse event remains unknow.Physician's opinion the cause was the procedure.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.The force issue identify during the analysis in the lab, is unrelated to the issue reported by the customer.It should be noted that product failure is multifactorial.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: incompatible component/ accessory (c0402) / investigation conclusions: cause traced to component failure (d02) / component code: circuit board (g02005) were selected as related to the force issue identified by bwi pal.Investigation findings: no device problem found (c19) / investigation conclusions no problem detected (d14) were selected as related to the adverse event.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2024, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Additionally, the manufactured date and expiration date have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: QDOT MICRO¿ CATHETER
• Common Device Name: 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: 18565081
• Report Number: 2029046-2024-00265
• Device Sequence Number: 18172049
• Product Code: OAE
• UDI-Device Identifier: 10846835017106
• UDI-Public: 10846835017106
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P210027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/23/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: D139403
• Device Lot Number: 31172428L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2024
• Supplement Date Received by Manufacturer: 02/08/2024; 02/28/2024
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 02/09/2024; 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BAYLIS NRG C0.; CARTO 3 SYSTEM.; UNKNOWN PUMP.; UNK_NGEN RF GENERATOR.
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 73 YR
• Patient Sex: Female