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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 40CC SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0475
Device Problem Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/13/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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, during the passage of the intra-aortic balloon(iab) the guide wire did not progress or at least came out, it was as if it was stuck and the doctor attributed it to a defect in the catheter. There was no reported injury to the patient.
 
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Brand NameLINEAR 7.5 FR. 40CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer (Section G)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
dorota wolpiuk
15 law drive
fairfield, NJ 07004
MDR Report Key9977079
MDR Text Key188202545
Report Number2248146-2020-00228
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K041281
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 06/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/16/2022
Device Catalogue Number0684-00-0475
Device Lot Number3000094243
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received06/24/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/16/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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