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

Model Number 0684-00-0576-01

Device Problem Leak/Splash (1354)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/19/2022

Event Type  Death  

Manufacturer Narrative

Additional initial reporter name & occupation - (b)(6), icu rn.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 blood was seen within the helium tubing.The customer was advised to stop therapy immediately and call the physician to remove the balloon within 30 minutes due to risk of thrombus.Upon follow up on (b)(6) 2022 at 8:44am, it was discovered that the physician ordered the staff to continue running the iab despite the instructions for use (ifu) stating to stop therapy and remove the iab.At 11:15am, received word from the local team that the physician elected not to remove the iab due to risk of thrombosis.Due to the patient¿s clinical condition, the team felt he would not tolerate being under anesthesia for a vascular procedure thus the iab was not removed.The patient was put on comfort care.At 1:43pm, received word from the local team that the patient expired with the iab in place as it was unable to be removed safely.

Event Description

N/a.

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: SENSATION PLUS 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: 16095587
• MDR Text Key: 306624578
• Report Number: 2248146-2023-00013
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112327
• 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: 04/11/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 0684-00-0576-01
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000255396
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2022
• Initial Date FDA Received: 01/04/2023
• Supplement Dates Manufacturer Received: 04/11/2023
• Supplement Dates FDA Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/23/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARDIOSAVE / CH342371J1.
• Patient Outcome(s): Death
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 95 KG