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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD MEGA 7.5FR. 30CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD MEGA 7.5FR. 30CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0292
Device Problems Break (1069); Detachment Of Device Component (1104); Material Rupture (1546)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/02/2017
Event Type  Injury  
Manufacturer Narrative
Although good faith efforts have been completed in attempt to retrieve the device, the device was not returned by the customer and therefore could not be evaluated. We are unable to confirm the reported event at this time. If new information becomes available, a supplemental report will be submitted. (b)(4).
 
Event Description
It was reported that the intra aortic balloon (iab) ruptured possibly due to calcification of patient's aorta. When the iab was removed a piece of the tip broke off and was retained inside patient. The patient was taken to cath lab to attempt to remove sheath and tip under fluoroscopy. The patient was then taken to operating room (or) for removal by vascular surgery.
 
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Brand NameMEGA 7.5FR. 30CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer (Section G)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
15 law drive
fairfield, NJ 07004
MDR Report Key6485909
MDR Text Key72555594
Report Number2248146-2017-00028
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120868
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 04/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/19/2018
Device Catalogue Number0684-00-0292
Device Lot Number3000011695
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/20/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/19/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/12/2017 Patient Sequence Number: 1
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