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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE MAHWAH CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0998-00-3023-XX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Aortic Dissection (2491)
Event Date 12/12/2017
Event Type  Death  
Manufacturer Narrative
This report has been sent per company protocol of co-reporting when the event description entails a serious injury or death regarding the iabp/ iab. The customer confirmed that there was no malfunction with the iabp, and iabp continues to be in clinical use. There was no further information provided. The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not reviewed as the serial number of the iabp was not provided by the customer.
 
Event Description
It was reported that while the cs300 intra aortic balloon pump (iabp) was providing therapy on triple vessel disease patient using a ymt30r-01 catheter, the patient expired due to bleeding by aorta dissection. Mild tortuosity and calcification were noted in the patient vessel. The customer is attributing the death to the iab. There was no malfunction of the iabp and it is not attributed to the patient death. The iab emdr was filed under (b)(4).
 
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Brand NameCS300
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 Key7187350
MDR Text Key97141301
Report Number2249723-2018-00060
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K063525
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 01/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0998-00-3023-XX
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 Received12/20/2017
Was Device Evaluated by Manufacturer? No Answer Provided
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: 01/12/2018 Patient Sequence Number: 1
Treatment
YAMATO PLUS-R 7.5FR. 30CC IAB
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