MAUDE Adverse Event Report: BIOSENSE WEBSTER INC ISMUS; CATHETER, ELECTRODE RECORDING

Catalog Number	D7R20P14RT
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	09/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation ablation procedure with a ismus and the patient experienced mitral valve insufficiency that required hospitalization.It was reported that during an afib procedure, a mitral regurgitation and a partial mi (mitral insufficiency) in the left atrium was noticed.During post mapping, the patients vitals were dropping drastically to the point where he almost went into cardiac arrest.The patient¿s blood pressure drastically dropping led to the discovery.The physician confirmed the injury with cardiac anesthesia.The patient was given epinephrine which helped with their blood pressure.The patient was then taken to the intensive care unit (icu) where his vitals came back to relatively normal.Two catheters were used during the procedure.The cause of the injury was reportedly due to scaring on the patient¿s left atrium and the mitral regurgitation.It was stated that "he looked like a sick patient".The patient improved.The physician's opinion on the cause of the adverse event was patient condition.
Additional Manufacturer Narrative
Device investigation details: an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Note: for field d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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: ISMUS
• Common Device Name: CATHETER, 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: 20424664
• Report Number: 2029046-2024-03364
• Device Sequence Number: 15558545
• Product Code: DRF
• UDI-Device Identifier: 10846835005950
• UDI-Public: 10846835005950
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K953768
• 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: Other
• Type of Report: Initial

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: D7R20P14RT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: FARAPULSE GENERATOR; OCTA,LNG,48P,3-3-3-3-3,F-CURVE; SMARTABLATE GENERATOR
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown