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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 34CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 34CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0469-01
Device Problem Difficult to Insert (1316)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 10/04/2021
Event Type  Death  
Manufacturer Narrative
Event site postal code: (b)(6). 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 during insertion of the intra-aortic balloon (iab) therapy in a patient with cardiac arrest post coronarography, the customer could not insert the guidewire through the iab and noted that the iab was broken after 12cm. A new iab was inserted without further issue. It was later reported that the patient had died. The customer does not attribute the patient's death to the device. This report is for the 1st iab used. A separate report will be submitted for the 2nd iab.
 
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Brand NameSENSATION 7FR. 34CC 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 Key12698910
MDR Text Key278401601
Report Number2248146-2021-00699
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567106755
UDI-Public10607567106755
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K063525
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,Followup,Followup
Report Date 01/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0684-00-0469-01
Device Catalogue Number0684-00-0433
Device Lot Number3000130347
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/21/2020
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/26/2021 Patient Sequence Number: 1
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