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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYP B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYP B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-53
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/25/2021
Event Type  Injury  
Manufacturer Narrative
(b)(6). A getinge service representative reported that this iabp unit was used with a yamato plus 30cc iab which was reported in mfg report number 2248146-2021-00389 (tw#473355). It was also reported that there was no anomalies or malfunction found on this cardiosave iabp unit. No blood was observed within the iabp unit, either. A supplemental report will be submitted when additional information is provided to us.
 
Event Description
It was reported that while removing the reported intra-aortic balloon (iab) catheter from the t-handle with maintaining vacuum by one-way valve, the physician encountered some resistance. Intra-aortic balloon(iab) therapy was started with this iab. After approximately three days of intra-aortic balloon (iab) therapy, the cardiosave intra-aortic balloon pump (iabp) console generated a check iab catheter alarm and went into standby mode. The helium tube was checked and blood was confirmed. The customer then attempted to remove the iab together with the sheath, but they felt resistance that the iab was caught by the blood vessel wall. A surgical incision was made and the iab was removed. It was noted that the patient did not have much calcification. The patient has been in stable condition. There was no reported malfunction on the iabp. A separate report has been submitted for the intra-aortic balloon(iab) under mfg report number 2248146-2021-00389.
 
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Brand NameCARDIOSAVE HYBRID TYP B PLUG
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer Contact
arelean guzman
1300 macarthur blvd
mahwah, NJ 
MDR Report Key12041596
MDR Text Key265003504
Report Number2249723-2021-01320
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108391
UDI-Public10607567108391
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 08/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number0998-00-0800-53
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Manufacturer Received08/19/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/28/2014
Is the Device Single Use? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 06/22/2021 Patient Sequence Number: 1
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