MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD MEGA 7.5FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0295-01

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

Patient Problems Stroke/CVA (1770); Convulsion/Seizure (4406)

Event Date 08/31/2021

Event Type  Death  

Manufacturer Narrative

Occupation: respiratory therapist.The device will not be 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 after approximately 14 days of intra-aortic balloon (iab) therapy, a change in patient mentation occurred including seizure activity and stroke alert.Approximately 30 minutes later, while the patient was being transported to ct scan blood was noted in the helium line and the tubing was clamped.The ct results regarding the stroke alert were negative.Approximately four hours later, the iab was removed.The insertion was reported to be right axillary, which is not the method described in the device instructions for use.Approximately six hours after the iab was removed, a new iab was placed via left axillary.It was later reported that another ct scan was taken three days later which showed a new stroke.The patient experienced left-sided weakness.Four days, later the patient was withdrawn from life support and expired.This report is for the second iab used in this event.A separate report was submitted under mfg report number 2248146-2021-00618 for the first iab.

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.Analysis of production (3331/213) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis (4109/213) - the review of the historical data was performed.Trend analysis (4110/213) - the overall complaint trend data for the period nov-2019 to oct-2021 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint #(b)(4).

• Brand Name: MEGA 7.5FR. 40CC 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: 12853317
• MDR Text Key: 281091842
• Report Number: 2248146-2021-00786
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107974
• UDI-Public: 10607567107974
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120868
• 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: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0684-00-0295-01
• Device Catalogue Number: 0684-00-0293
• Device Lot Number: 3000175189
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/07/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AUTOCAT 2 WAVE CONSOLE
• Patient Outcome(s): Death
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 96 KG