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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0567
Device Problems Leak/Splash (1354); Material Rupture (1546)
Patient Problems Low Blood Pressure/ Hypotension (1914); Injury (2348); Low Oxygen Saturation (2477); Vascular System (Circulation), Impaired (2572); Diminished Pulse Pressure (2606)
Event Type  Injury  
Manufacturer Narrative
The product has been returned to the manufacturer, but is pending investigation. Once the investigation is completed a supplemental report with our findings will be submitted. Reference complaint # (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the balloon ruptured while inside the patient. The patient experienced a drop in their hemodynamic levels initially, but eventually stabilized.
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the balloon ruptured while inside the patient. The patient experienced a drop in their hemodynamic levels initially, but eventually stabilized.
 
Manufacturer Narrative
Additional information - serial number - (b)(4), lot number - 3000084492. The product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter and between the catheter and the sheath. The returned sheath was a non-maquet device. An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and one leak was detected on the membrane approximately 0. 3cm from the rear seal measuring 0. 038cm in length. The reported problem was most likely triggered by a leak which was found on the membrane. Under magnification, a whitish patch was observed around the leak. This whitish patch is the typical appearance of an abrasion mark which is caused by calcified plaque in the aorta. A device and lot history record review was completed for the reported product. No nonconformances were found that are considered to be related to the event. (b)(4).
 
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Brand NameSENSATION PLUS 7.5FR. 40CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key8424585
MDR Text Key138921067
Report Number2248146-2019-00212
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K122628
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2021
Device Catalogue Number0684-00-0567
Device Lot Number3000084492
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/06/2019
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received04/29/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/15/2019 Patient Sequence Number: 1
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