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U.S. Department of Health and Human Services

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

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DATASCOPE FAIRFIELD SENSATION PLUS 8FR. 50CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0575
Device Problems Mechanical Problem (1384); Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/25/2018
Event Type  malfunction  
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. (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) insertion, the sheath ¿crimped¿ at the insertion site. The sheath was removed and a competitor's sheath was used. However, the iab would not advance through the competitor's sheath either. A new iab was used and was able to be inserted through the competitor's sheath. The indication for use was stemi (st-elevation myocardial infarction) with cardiogenic shock. There was no reported injury to the patient.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood on the exterior of the catheter. The sheath was not returned for evaluation. One kink was found on the catheter tubing near the y-fitting approximately 76. 2cm from the iab tip. A laboratory insertion test was unable to be performed due to the membrane being unfurled. 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 the sheath was not returned, the returned condition of the catheter, and we are unable to mimic the clinical setting. An evaluation of the product was unable to duplicate the reported problem. The product performed according to specification. A device and lot history record review was completed for the reported product. No non-conformances were found that are considered to be related to the event. (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) insertion, the sheath ¿crimped¿ at the insertion site. The sheath was removed and a competitor's sheath was used. However, the iab would not advance through the competitor's sheath either. A new iab was used and was able to be inserted through the competitor's sheath. The indication for use was stemi(st-elevation myocardial infarction) with cardiogenic shock. There was no reported injury to the patient.
 
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Brand NameSENSATION PLUS 8FR. 50CC 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 Key7662361
MDR Text Key113305451
Report Number2248146-2018-00428
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112327
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/19/2021
Device Catalogue Number0684-00-0575
Device Lot Number3000067897
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/26/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received07/31/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/19/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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