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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
Model Number 0684-00-0480-01
Device Problems Off-Label Use (1494); Material Deformation (2976)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/02/2021
Event Type  malfunction  
Manufacturer Narrative
Event site postal code: (b)(6). The product has been returned to the manufacturer, but is pending investigation. Once the investigation is completed a supplemental report with our findings will be submitted. Complaint record id #: (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the iab was attached the patient's chest leaving a "c"-shaped loop in the iab which bends and kinks and blocks a lot of patient movement. The insertion was reported to be axillary, which is not the method described in the device instructions for use. This is the fourth iab the customer has had this issue with during this event. There was no patient harm or adverse event reported. This report is for the fourth iab used in this event. Separate reports will be sent for first, second, and third iabs used.
 
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Brand NameLINEAR 7.5 FR. 40CC IAB
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 Key11366493
MDR Text Key233116106
Report Number2248146-2021-00116
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
K041281
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0684-00-0480-01
Device Catalogue Number0684-00-0475
Device Lot Number3000114160
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/17/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/31/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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