MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0470-01

Device Problems Filling Problem (1233); Off-Label Use (1494)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2021

Event Type  malfunction  

Manufacturer Narrative

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 console repeatedly indicated that there was an auto-fill failure and was unable to resume pumping. The customer had tried two consoles and experienced the same issue. The insertion was reported to be axillary, which is not the method described in the device instructions for use. The customer was made aware of the off-label use. They then attempted pressing the fill key, but that was not successful. There were no visible kinks in the iab and no blood seen in the helium tubing. It was also confirmed that there was helium displayed in the tank. Due to the inability to restart pumping, the customer was then advised to consider removal/ replacement of the iab. There was no patient harm or adverse event reported.

• Brand Name: SENSATION 7FR. 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: dorota wolpiuk ; 15 law drive; fairfield, NJ
• MDR Report Key: 11922772
• MDR Text Key: 253809238
• Report Number: 2248146-2021-00348
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 0684-00-0470-01
• Device Catalogue Number: 0684-00-0434
• Device Lot Number: 3000134828
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/16/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/20/2020
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/02/2021 Patient Sequence Number: 1

Treatment

UNKNOWN.