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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH UNKNOWN IABP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH UNKNOWN IABP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Cardiogenic Shock (2262); Injury (2348)
Event Date 06/01/2020
Event Type  Injury  
Manufacturer Narrative
The pump model and serial number of the involved iabp has not been reported to us. Additionally, there was no reported malfunction of the involved iabp; however, additional information has been requested, and if received, we will submit a supplemental report. Returned to manufacturer.
 
Event Description
It was reported that during use on a patient it was reported that after approximately two days of an unknown intra-aortic balloon pump (iabp) therapy, the intra-aortic balloon catheter (iabc) ruptured. The insertion was reported to be axillary, which is off-label use. The patient reportedly experienced a cerebrovascular accident (cva) and went into cardiogenic shock. There was no reported malfunction of the iabp involved in the event. The patient was subsequently placed on hospice care. From medwatch mfg report number mw5094864: there was a reported injury to the patient. Patient was taken to interventional radiology for potential thrombectomy; however, this was limited by lack of flow. Hemorrhagic conversion of the cva and patient went into cardiogenic shock. Patient was the discharged from the facility to hospice. Please refer to mfg report number 2248146-2020-00305 for information on the involved iabc.
 
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Brand NameUNKNOWN IABP
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer Contact
dorota wolpiuk
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key10477819
MDR Text Key205160133
Report Number2249723-2020-01396
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 09/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/07/2020
Was Device Evaluated by Manufacturer? No
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: 09/01/2020 Patient Sequence Number: 1
Treatment
SENSATION PLUS 40CC
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