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

Catalog Number	D7A20131RT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/24/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device investigation details: an analysis of the product could not be performed since a physical sample was not received for evaluation.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Note: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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 ref.(b)(4).
Event or Problem Description
It was reported that a patient underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a webster cs and a crista cath and the patient experienced cardiac arrest and hemorrhage that resulted in death.The patients pressure dropped significantly during transesophageal echocardiogram (tee) prior to transeptal puncture.After this was noticed, cardiopulmonary resuscitation (cpr) was administered.The patients' pressure would recover slightly and then fall again - all while going in and out of ventricular tachycardia (vt).Patient was shocked back into normal rhythm when needed.Interventional radiology (ir) was called to check for aortic and retroperitoneal bleed with no findings.Cardio vascular (cv) surgery was called and placed the patient on ecmo.The patient was stable and on ecmo and then shortly after the patient started to code.Cv surgery, ir and eps were all in the room attempting to figure out the problem.It was noticed the patient¿s abdomen was distended.Physicians surgically opened the belly and found the abdomen was full of blood.After a long-standing effort, anesthesia said the pupils were non-reactive and blown.The cause of the bleed remains unknown to all the physicians and family did not want to do an autopsy.No ablation or transeptal puncture had occurred.The physician's opinion on the cause of the adverse event was patient condition.Significant history includes ventricular aneurysm, severe coronary disease and prior to the case an echo showed lv function of 40%.The echo was taken a few days before the procedure.

• Brand Name: CRISTA CATH
• 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: 20019351
• Report Number: 2029046-2024-02750
• Device Sequence Number: 8748072
• Product Code: DRF
• UDI-Device Identifier: 10846835005042
• UDI-Public: 10846835005042
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: D7A20131RT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: BI DIR 7FR DEF CS,F-J,12 PIN; CARTO 3 SYSTEM; GENERATOR G4C-0718; GENERATOR G4CP-0737
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male