MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH UNKNOWN; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 02/14/2020

Event Type  Death  

Manufacturer Narrative

The production device history record (dhr) for this iabp unit cannot be reviewed since the serial number for the unit was not provided.The customer has not requested repair of the unit as there was no malfunction of the iabp.A supplemental report will be submitted if additional information is provided.

Event Description

The patient was taken to the cardiac theatre for emergency surgery @ (b)(6) private hospital on (b)(6) 2020.The patient arrested in operating theatre prior to the commencement of surgery.A clinical decision to put in an iab was made.During a prolonged resuscitation process, the physicians attempted the insertion of 3 iab catheters.The first attempt was at 10:03 am.Resuscitation was unsuccessful and patient time of death was 11:14am.The facility was unsure if the iabp therapy had ever actually started during the resuscitation and prior to the patient¿s death.The intra-aortic balloon pump (iabp) in use during the event is unknown.It was reported that at that time of the event, there was no thought that the iab was any part contributing to the death of this patient.Due to the patient death occurring in the hospital, the patient was sent to have an autopsy by the coroner and a subsequent report was sent to the hospital in (b)(6) 2021.The cause of death was stated as pulmonary artery tear.The notes also said there was an aortic rupture complicated from iab insertion and and iab catheter rupture.The coroner¿s report asked if the device manufacturer had been notified, hence the initial call from the clinical services director was received.This report is for the iabp in use during the event.The iab catheters are being reported separately.

Manufacturer Narrative

Updated fields: b4, b6, g3, g6, g7, h2, h10.

Event Description

N/a.

• Brand Name: UNKNOWN
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 11378586
• MDR Text Key: 233495430
• Report Number: 2249723-2021-00400
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: No
• 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: BALLOON CATHETERS:MEGA 50CCMEGA 30CC; BALLOON CATHETERS:MEGA 50CCMEGA 30CC
• Patient Outcome(s): Death
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 59 KG