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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0575
Device Problem Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/06/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6). 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. (b)(4).
 
Event Description
It was reported that during insertion of the intra-aortic balloon (iab), the balloon was unable to be advanced. The balloon was replaced to start therapy. There was no reported injury to the patient.
 
Event Description
It was reported that during insertion of the intra-aortic balloon (iab), the balloon was unable to be advanced. The balloon was replaced to start therapy. There was no reported injury to the patient.
 
Manufacturer Narrative
Concomitant medical products- serial# from: unknown to: 30000904340666. Return to manufacture date from: [blank] to: 07/22/2019. The product was returned with the membrane completely unfolded and blood on the exterior of the catheter. A laboratory insertion test was unable to be performed due to the membrane being unfurled. The technician then attempted to insert a laboratory 0. 025¿ guide wire through the inner lumen of the returned iab and was successful. An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected. A leak may impact the ability to maintain vacuum. We are unable to confirm the reported difficulty during insertion because of the returned condition of the catheter and we are unable to mimic the clinical setting. A production record review was completed for the reported product. No nonconformances were found that are considered to be related to the event. Reference complaint #(b)(4).
 
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Brand NameSENSATION PLUS 8FR. 50CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key8734223
MDR Text Key149185332
Report Number2248146-2019-00560
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K112327
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/07/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/02/2022
Device Catalogue Number0684-00-0575
Device Lot Number3000090434
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/22/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2019
Is This a Reprocessed and Reused Single-Use Device? No

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