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U.S. Department of Health and Human Services

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

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DATASCOPE FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0567
Device Problems Reflux within Device (1522); Device Contamination with Body Fluid (2317)
Patient Problem No Code Available (3191)
Event Date 08/12/2016
Event Type  malfunction  
Manufacturer Narrative
Date was not entered in the initial mdr. Manufacturer date: 08/12/2016.
 
Event Description
Shortly after a bedside insertion the staff reported seeing blood in the helium tubing. Dr. (b)(6) denied difficulty on insertion due to the act levels being elevated. The resistance was extreme and a surgical removal was arranged when the act declined.
 
Manufacturer Narrative
The device has not been returned to the manufacturer and we're unable to complete an evaluation on the affected product. When its' provided we will send a supplemental report with additional findings. We continue in our efforts to follow up with the customer for its' return. (b)(4).
 
Event Description
Shortly after a bedside insertion the staff reported seeing blood in the helium tubing. Dr. (b)(6) denied difficulty on insertion due to the act levels being elevated. The resistance was extreme and a surgical removal was arranged when the act declined.
 
Manufacturer Narrative
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. One kink was found on the catheter tubing approximately 34. 3cm from the iab tip. An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extension tubing was performed and one leak was detected on the membrane approximately 1. 5cm 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. Complaint # (b)(4). Supplement - device evaluation.
 
Event Description
Shortly after a bedside insertion the staff reported seeing blood in the helium tubing. Dr (b)(6) denied difficulty on insertion due to the act levels being elevated. The resistance was extreme and a surgical removal was arranged when the act declined.
 
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Brand NameSENSATION PLUS 7.5FR. 40CC 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 Key5906744
MDR Text Key269739774
Report Number2248146-2016-00070
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122628
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/21/2019
Device Catalogue Number0684-00-0567
Device Lot Number3000026131
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/12/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/22/2016
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: 08/26/2016 Patient Sequence Number: 1
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