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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 Difficult to Flush (1251); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/24/2020
Event Type  malfunction  
Manufacturer Narrative
Additional initial reporter name: (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 insertion of the intra-aortic balloon (iab), the guide wire could not pass through the lumen. The customer attempted inserting the guide wire again, but was unsuccessful. The customer then attempted to flush the lumen, and realized there was an obstruction. The iab was then replaced with a new one. There was no patient harm, or adverse event reported.
 
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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 Key11072448
MDR Text Key223796339
Report Number2248146-2020-00682
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567106564
UDI-Public10607567106564
Combination Product (y/n)N
Reporter Country CodeBU
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 01/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/27/2022
Device Model Number0684-00-0480-01
Device Catalogue Number0684-00-0475
Device Lot Number3000102613
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/20/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/27/2019
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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