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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - FAIRFIELD UNKNOWN IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Aortic Dissection (2491)
Event Type  Injury  
Manufacturer Narrative
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. Complaint record id # (b)(4).
 
Event Description
It was reported via a medical article that, a (b)(6)-year-old male was admitted in the setting of protracted chest pain, st segment abnormalities, and elevated troponin. Angiography revealed severe triple vessel disease, left main coronary artery stenosis, and severe left ventricular systolic dysfunction on ventriculography. Continued chest discomfort and hemodynamic instability prompted insertion of an intraaortic balloon pump (iabp) via the right femoral artery with fluoroscopy. Coronary artery bypass grafting was planned for the following day after transthoracic echocardiography. Examination of the descending aorta with intraoperative trans-esophageal echocardiography (tee) identified an intimal dissection flap with the intra-aortic balloon pump(iabp) positioned within the false lumen. Diastolic augmentation was being achieved through compression of the true lumen. The tip of the intra-aortic balloon pump (iabp) disrupted a region of grade v atheroma in the proximal descending aorta. An associated intimal tear demonstrated flow from the true to the false lumen during systole. We were unable to see how far the dissection extended proximally or distally; however, the lesion was identified in the distal aortic arch and descending aorta. The dissection was not seen in the ascending aorta, implying it ended somewhere in the aortic arch. Weaning of intra-aortic balloon pump(iabp) counterpulsation while augmenting inotropic support resulted in deteriorating hemodynamics. A guidewire was inserted into the left femoral artery, and after confirming position within the true lumen on tee, a second iabp was inserted. Augmentation within the true lumen commenced after the first intra-aortic balloon pump(iabp) device was removed. The possibility that the new iabp crossed the intimal flap along its course could not be excluded, and the proximal and distal extremes of the dissection were unknown. The procedure was postponed, and computed tomography (ct) aortography was performed. A type b aortic dissection was demonstrated extending from the distal aortic arch to the iabp insertion site in the right common femoral artery. The iabp did not cross the dissection flap at any point. Uneventful coronary artery bypass surgery was performed 72 hours later, and the patient was discharged home for ongoing follow-up and conservative management of the aortic pathology.
 
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Brand NameUNKNOWN IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer (Section G)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
dorota wolpiuk
15 law drive
fairfield, NJ 07004
MDR Report Key9508149
MDR Text Key183309979
Report Number2248146-2019-00945
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 12/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received12/04/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/21/2019 Patient Sequence Number: 1
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