MAUDE Adverse Event Report: BIOSENSE WEBSTER INC DECANAV ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Catalog Number	R7D282CT
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	02/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 12-mar-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.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.Note: this event was previously assessed as mdr reportable against a qdot micro¿ catheter under mfr # 2029046-2024-00816.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 a supraventricular tachycardia ablation procedure with a decanav electrophysiology catheter and the patient experienced cardiac tamponade treated with a pericardiocentesis and 450 ccs of fluid was drained.When checking intracardiac echocardiography (ice) post-procedure, they saw an effusion.The patient's blood pressure dropped and the patient began complaining of chest pain.Confirmed effusion using both ice and an external echocardiogram.The patient was going to the intensive care unit (icu) for observation.Patient outcome was improved.No transseptal puncture performed.No evidence of steam pop.Event occurred during mapping and no ablation had occurred.On (b)(6) 2024, additional information was received indicating the qdot micro¿ catheter was not in the body yet at the time of incident as previously reported.It was later clarified that the soundstar and cs catheters were in the body at the time of incident.As such, the event is being reported against the decanav electrophysiology catheter since it is in direct contact with cardiac tissue.The soundstar catheter is not the most suspected device.
Additional Manufacturer Narrative
It was reported a patient underwent a supraventricular tachycardia ablation procedure with a decanav electrophysiology catheter and the patient experienced cardiac tamponade treated with a pericardiocentesis and 450 ccs of fluid was drained.When checking intracardiac echocardiography (ice) post-procedure, they saw an effusion.The patient's blood pressure dropped and the patient began complaining of chest pain.Confirmed effusion using both ice and an external echocardiogram.The patient was going to the intensive care unit (icu) for observation.Patient outcome was improved.Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation was 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 no issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.In addition, no device malfunction was reported, 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.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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: DECANAV ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 19122559
• Report Number: 2029046-2024-01267
• Device Sequence Number: 7628990
• Product Code: DRF
• UDI-Device Identifier: 10846835008791
• UDI-Public: 10846835008791
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K080425
• 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
• Report Date (Section B): 04/16/2024

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 Expiration Date: 01/04/2025
• Device Catalogue Number: R7D282CT
• Device Lot Number: 31221638M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2024
• Supplement Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: 7FR DECAN,11P,D,2.4MMLE,282MM.; DEF 6F,4P,D,SD,252,10RDL,92CM.; NGEN RF GENERATOR, US.; QDOT MICRO, BI, TC, D-F.; SOUNDSTAR ECO SMS 8F CATHETER.; UNK_CARTO 3.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 100 KG