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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. / MAQUET LINEAR SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. / MAQUET LINEAR SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Device Problem Material Rupture (1546)
Patient Problem No Code Available (3191)
Event Date 05/05/2017
Event Type  malfunction  
Event Description
Balloon of iabp catheter ruptured - blood was noted in line. The patient had a procedure in cath lab to remove the defective catheter.
 
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Brand NameLINEAR
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. / MAQUET
15 law dr.
fairfield NJ 07004
MDR Report Key6581377
MDR Text Key75663775
Report Number6581377
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
Type of Report Initial
Report Date 05/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Other Device ID Number7.5FR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/09/2017
Event Location Hospital
Date Report to Manufacturer05/09/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/22/2017 Patient Sequence Number: 1
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