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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION PLUS 7.5FR. 40CC IAB ACCESSORIES SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. SENSATION PLUS 7.5FR. 40CC IAB ACCESSORIES SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0568-01
Device Problem Material Rupture (1546)
Patient Problem No Information (3190)
Event Date 01/19/2018
Event Type  malfunction  
Event Description
Balloon tubing had blood in it, as if the balloon had ruptured. Md examined the balloon and could not find a hole. Md removed the balloon. Manufacturer response: for maquet sensation 7. 5fr/ 40cc balloon catheter, (brand not provided) (per site reporter). Product was returned to manufacturer for evaluation.
 
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Brand NameSENSATION PLUS 7.5FR. 40CC IAB ACCESSORIES
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP.
15 law dr
fairfield NJ 07004
MDR Report Key7298816
MDR Text Key101023417
Report Number7298816
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 02/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/27/2018
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0684-00-0568-01
Device Catalogue Number0684-00-0568-01
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/02/2018
Event Location Hospital
Date Report to Manufacturer02/02/2018
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

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