MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD MEGA 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0296-01

Device Problem Gas/Air Leak (2946)

Patient Problems Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Ventricular Fibrillation (2130)

Event Date 11/02/2022

Event Type  Injury  

Manufacturer Narrative

Additional contact person information - (b)(6).The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id # (b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy the patient had a brief ventricular fibrillation (vt) arrest requiring advanced cardiovascular life support (acls) and shock two times.Afterwards, patient was in a tachycardic rhythm, it is unknown which one.The cardiosave intra-aortic balloon pump (iabp) then generated a gas loss in iab circuit alarm and stopped pumping.No blood was in the gas line and connections were tight.The iabp restarted via start button but would only pump for a few seconds then stop with the same alarm again.It was decided to switch to another iabp as blood pressures and patient condition were tenuous.The switch was successful immediately.The patient then went to cath lab to be re-cannulated for venoarterial extracorporeal membrane oxygenation (va ecmo).This report is for the iab.A separate report has been submitted for the cardiosave iabp under mfg report number 2249723-2022-02907.

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.Reference complaint #(b)(4).

• Brand Name: MEGA 8FR. 50CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 16018528
• MDR Text Key: 305871685
• Report Number: 2248146-2022-01005
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0684-00-0296-01
• Device Catalogue Number: 0684-00-0497
• Device Lot Number: 3000247117
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/06/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARDIOSAVE / CH338672F1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 77 KG