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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
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).
 
Manufacturer Narrative
**udi related data quality updates only** providing updated device identification information in alignment with gudid (d1, d2, d3, d4, g4, h4, h5).Complaint record id # (b)(4).
 
Event Description
N/a.
 
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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 Key18615162
MDR Text Key334217774
Report Number2248146-2024-00061
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567109718
UDI-Public10607567109718
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K041281
Number of Events Reported1
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0684-00-0475
Device Lot Number3000330593
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/12/2024
Initial Date FDA Received01/31/2024
Supplement Dates Manufacturer Received02/07/2024
Supplement Dates FDA Received02/08/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/09/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Treatment
I PEX PRESSURE MONITORING KIT
Patient Age74 YR
Patient SexMale
Patient Weight65 KG
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