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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH SYS98XT SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE MAHWAH SYS98XT SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Folded (2630)
Patient Problems Death (1802); Myocardial Infarction (1969)
Event Date 01/30/2018
Event Type  Death  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) will be reviewed as soon as the dhr is made available, and a supplemental report will be provided if necessary. The company representative from the business unit has advised that the customer has not alleged a malfunction of the iabp, and that the iabp remains in clinical use.
 
Event Description
It was reported that during sys98xt intra-aortic balloon pump (iabp) therapy, upon opening the balloon package, a fold was found on the catheter. The customer indicated that something may have been wrong with the catheter and opened another package and iabp therapy was initiated. The indication for use was acute myocardial infarction (ami). Subsequently, the patient died on (b)(6) 2018 as a result of heart disease after iabp therapy. The customer has confirmed that the patient's death is not attributed in any way with the iabp. Separate reports will be submitted on the two balloon catheters under complaints (b)(4).
 
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Brand NameSYS98XT
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd.
mahwah, NJ 07430
MDR Report Key7293185
MDR Text Key100842494
Report Number2249723-2018-00300
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K961509
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 02/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-0479-XX
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received01/31/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/01/1997
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 02/23/2018 Patient Sequence Number: 1
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