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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. SENSATION 7FR. 34CC IAB WITH ACCESSORIES, US ONLY SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0469-01U
Device Problem Failure to Advance (2524)
Patient Problem Insufficient Information (4580)
Event Date 10/03/2020
Event Type  malfunction  
Event Description
During insertion the balloon was not able to pass through sheath. Balloon not able to pass approximately past 2/3 into sheath.
 
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Brand NameSENSATION 7FR. 34CC IAB WITH ACCESSORIES, US ONLY
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP.
15 law drive
fairfield NJ 07004
MDR Report Key10860069
MDR Text Key216865541
Report Number10860069
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/16/2020,10/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0684-00-0469-01U
Device Catalogue Number0684-00-0469-01U
Device Lot Number3000121304
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/16/2020
Event Location Hospital
Date Report to Manufacturer11/18/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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