MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH UNKNOWN INTRA-AORTIC BALLOON PUMP; 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); Low Blood Pressure/ Hypotension (1914)

Event Date 03/02/2021

Event Type  Injury  

Manufacturer Narrative

The production device history record (dhr) for this iabp unit cannot be reviewed per getinge standard operationg procedure since the serial number for the unit was not provided.There was no reported malfunction of the intra-aortic balloon pump (iabp).A supplemental will be submitted if further information is provided.(b)(6).

Event Description

Medwatch received on 16-march-2021.The patient was about to have emergent coronary angiography, became hypotensive, developed vf and received multiple rounds of defibrillation, cardiopulmonary resuscitation (cpr) and inotropes.The team then placed an iabp.The patient arrested again and received @6 minutes cardiopulmonary resuscitation (cpr) with aggressive resuscitation efforts.A 40cm iabp was placed in excellent position and set at 1:1.There was initially excellent augmentation however, over several minutes time the map persistently dropped requiring confirmation of central pressures with the use of an omniflush catheter placed in the proximal aorta.Again, the patient became hypotensive to the 40s systolic despite aggressive inotropes.The balloon pump waveform had an odd appearance that suggested the patient had no underlying native pressure.This was confirmed by putting the balloon pump on hold which demonstrated no native pressure.Aggressive cardiopulmonary resuscitation (cpr) and resuscitative efforts were reinstituted for an additional 5 minutes which did not result in restoration of a perfusing pressure or rhythm.Therefore all further efforts at resuscitation.This report is for the unknown intra-aortic balloon pump used in the reported event.A separate medwatch report is being submitted for the intra-aortic balloon (iab) catheter used.

Manufacturer Narrative

Updated fields; b4, g3, g6, g7, h2, h6, h10.This complaint record is being closed due to insufficient information after three (3) good faith efforts (gfe) attempts were made to the customer to obtain additional information on this complaint event.No response has been received, therefore this complaint is being closed.If information is received, we will reopen and update the complaint.

Event Description

N/a.

• Brand Name: UNKNOWN INTRA-AORTIC BALLOON PUMP
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 11608625
• MDR Text Key: 243929416
• Report Number: 2249723-2021-00703
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• 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: 08/24/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: SENSATION PLUS 40CC IAB & OMNIFLUSH CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 82 KG