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

Catalog Number 0684-00-0475

Device Problem Pressure Problem (3012)

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

Event Date 01/11/2024

Event Type  malfunction  

Event Description

It was reported that after 20 hours of intra-aortic balloon (iab) therapy, the console generated a check iab catheter alarm and the augmentation could not be obtained.It was noted that a flush system was connected.The iab was removed after 23 hours of therapy.There was no patient harm or adverse event reported.

Manufacturer Narrative

Complete event site name: (b)(6).Event site postal code: (b)(6).The device was not returned and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.Complaint record id # (b)(4).

Event Description

N/a.

Manufacturer Narrative

Photographs were provided by the facility.The photograph shows the iab with the membrane completely unfolded and blood on the interior and exterior of the catheter tubing and membrane.A video was also provided which shows the pump alarming "check iab catheter".No decon or visual inspection performed since product was not returned and could not be evaluated.Based on the video and photographic evidence provided by the facility, the reported failures "alarm, check iab catheter" & "difficult/ unable to monitor pressure (augmentation)" are confirmed due to a leak.However, since the product was not returned, we were unable to evaluate the device.Therefore, we are unable to determine a root cause.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Reference complaint # (b)(4).

• Brand Name: LINEAR 7.5 FR. 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: 18615162
• MDR Text Key: 334217774
• Report Number: 2248146-2024-00061
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567109718
• UDI-Public: 10607567109718
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K041281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 3000330593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: I PEX PRESSURE MONITORING KIT
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 65 KG