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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD MEGA 8FR. 50CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD MEGA 8FR. 50CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0296-02
Device Problems Leak/Splash (1354); Difficult to Remove (1528)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/12/2022
Event Type  Injury  
Manufacturer Narrative
Occupation: administrator/ supervisor. 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). Device not returned.
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, a balloon rupture occurred. The insertion was reported to be axillary, which is not the method described in the device instructions for use. Upon removal, it was noted that the ruptured iab was crumpled and became difficult to remove. The patient required a larger incision to remove the iab. A new iab was inserted to continue therapy.
 
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Brand NameMEGA 8FR. 50CC IAB
Type of DeviceSYSTEM, 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 Key13523594
MDR Text Key285542762
Report Number2248146-2022-00112
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091449
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0684-00-0296-02
Device Catalogue Number0684-00-0497
Device Lot Number3000114163
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received02/22/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/05/2020
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/14/2022 Patient Sequence Number: 1
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