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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - MAHWAH UNKNOWN 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 Problem Death (1802)
Event Date 04/01/2019
Event Type  Death  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) unit was unable to be reviewed as we were not able to obtain the serial number for the iabp associated with this complaint. The device has not been returned to the manufacturer so we are unable to complete an evaluation. If provided we will send a supplemental report with our additional findings. Device not returned.
 
Event Description
Please refer to mfg report number 2248146-2020-00157 for the related intra-aortic balloon catheter. Last april, the (b)(6) received news of an unfortunate event regarding the death of a (b)(6) yo male patient. The patient was being treated for coronary artery stenting following an mi. Shortly into the procedure, following contrast media infusion, guidewire placement and balloon catheter angioplasty, he complained of being unwell (and a ¿burning sensation¿ in his head?) and rapidly deteriorated on the table and suffered heart failure. It is suggested by the treating cardiologist that the patient experienced a sudden deterioration related to possible anaphylaxis and that this could be have been induced by polyethylene glycol (peg) exposure. The patient had a prior diagnosis of allergy to peg. It is not clear whether the patient suffered a fatal cardiac arrest due to their existing cardiac disorder and treatment, or whether this deterioration was indeed anaphylaxis and directly/indirectly brought on by exposure to peg. The pathologist has not ruled out this possibility. Recently, hm coroner has provided medical records to properly interested persons including (b)(6), and in those medical records is a page on ¿equipment barcodes¿ and details of devices used to treat the patient. One device is listed to be a sensation plus 8 fr, 50cc iab catheter manufactured by getinge.
 
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Brand NameUNKNOWN
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 Key9888846
MDR Text Key185247673
Report Number2249723-2020-00510
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUK
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 03/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2020
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2020
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: 03/27/2020 Patient Sequence Number: 1
Treatment
SENSATION PLUS 8 FR 50CC IAB
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