Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0575
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/27/2019
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.Complaint # (b)(4).
 
Event Description
It was reported during intra-aortic balloon (iab) therapy, blood was seen in the tubing.The balloon was replaced without further issue.The insertion was reported to be axillary, which is not the method described in the device instructions for use.There was no reported injury to the patient.
 
Manufacturer Narrative
Corrected section: d4 - 'serial#' changed from (b)(6).The product was returned with the membrane completely unfolded with blood on the exterior and interior of the catheter.A catheter tubing/inner lumen break was observed near the y-fitting at approximately 76.2cm from the iab tip.Additionally, the sensor cable was returned cut at approximately 40.1cm from the rear of the y-fitting.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and one leak was detected at the catheter tubing/inner lumen break site.The break found in the inner lumen appears to have been the result of a severe kink which eventually failed and allowed blood to leak into the membrane and catheter tubing, causing the reported problem.However, it is difficult to determine when the break occurred.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.Complaint record # (b)(4).
 
Event Description
It was reported during intra-aortic balloon (iab) therapy, blood was seen in the tubing.The balloon was replaced without further issue.The insertion was reported to be axillary, which is not the method described in the device instructions for use.There was no reported injury to the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SENSATION PLUS 8FR. 50CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key9501310
MDR Text Key189094924
Report Number2248146-2019-00939
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 01/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/12/2022
Device Catalogue Number0684-00-0575
Device Lot Number3000101660
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2019
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 12/02/2019
Initial Date FDA Received12/20/2019
Supplement Dates Manufacturer Received01/16/2020
Supplement Dates FDA Received01/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age66 YR
Patient Weight128
-
-