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 Problems Filling Problem (1233); Material Deformation (2976)

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

Event Date 05/04/2021

Event Type  malfunction  

Manufacturer Narrative

Complete event site name: (b)(6) medical center (b)(6) division. 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 after three days of intra-aortic balloon (iab) therapy, the customer was helping the patient out of bed and the console generated a leak in circuit alarm several times and then an auto-fill failure alarm. The insertion was reported to be axillary, which is not the method described in the device instructions for use. There was no blood in the tubing and chest films did not show any internal kinks. The customer attempted several auto-fills and was able to get the console pumping again. However, several minutes later the console once again indicated that there was a leak. The customer tried to auto-fill again, but it had failed. The physician, who was at the bedside, reported that there was a severe kink where they had "looped" the helium tubing the secure it to the patient's upper extremity. The physician removed the kink, but still could not fill the iab. It was then decided to replace the iab. The patient was stable at this point. There was no patient harm or adverse event reported.

• 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: dorota wolpiuk ; 15 law drive; fairfield, NJ
• MDR Report Key: 11876605
• MDR Text Key: 252393172
• Report Number: 2248146-2021-00332
• Device Sequence Number: 1
• Product Code: DSP
• 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: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/01/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 0684-00-0295-01
• Device Catalogue Number: 0684-00-0293
• Device Lot Number: 3000116949
• 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: 07/01/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/13/2020
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial