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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 0684-00-0498-01
Device Problem Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/22/2022
Event Type  malfunction  
Event Description
It was reported that during insertion of the intra-aortic balloon (iab), the guidewire could not be inserted through the lumen due to the lumen being blocked. A new iab was inserted successfully. There was no patient harm or adverse event reported.
 
Manufacturer Narrative
Complete event site name: (b)(6) hospital. Event site postal code: (b)(6). The device has been returned to the factory and is being evaluated. A supplemental report will be submitted when the evaluation is completed. Complaint record id # (b)(4).
 
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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 Key14106615
MDR Text Key289255128
Report Number2248146-2022-00298
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K091449
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/13/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0684-00-0498-01
Device Catalogue Number0684-00-0497
Device Lot Number3000172392
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/11/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/25/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/24/2021
Is the Device Single Use? Yes
Type of Device Usage Initial

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