• 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. SENSATION 7FR 34CC IAB 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. SENSATION 7FR 34CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-9992
Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591)
Patient Problem Death (1802)
Event Date 05/27/2016
Event Type  Death  
Manufacturer Narrative
Correction: date was not entered in the initial mdr. Date: (b)(6) 2016.
 
Event Description
The balloon catheter was inserted while attached to the balloon pump, everything appeared to be okay. The patient's anatomy was tortuous and a longer than normal sheath was necessary. The augmentation was initially ok but then it appeared low. It was determined that there was a problem with the pressure bag, it was changed out and then the augmentation appeared to be okay again. After about 15 minutes the pump stopped and alarmed, "check iab catheter. " the clinicians checked all connections, checked for blood in the tubing, checked the position of the catheter, and even asked the md to ensure that the catheter was properly positioned. The patient's condition started to deteriorate during this time. The clinicians double checked everything in the help menu on the balloon pump and attempted to restart the pump and received another message, "check iab catheter. " the ¿check iab catheter¿ alarm could not be resolved and the decision was made to put the patient on the impella rather than another iab/pump. The patient was coding when they first had him on the impella but then after an hour he died and the iab was discarded.
 
Manufacturer Narrative
On (b)(6) 2016 06:05 pm (gmt-4:00) added by (b)(6) (b)(4): the iab was not returned and so it could not be evaluated. A ship history review and trend evaluation was completed for the reported product. No nonconformances were found that are considered to be related to the event. Evaluation of device could not be performed since it was not returned. No root cause could be identified for fir/capa evaluation. The complaint could not be confirmed.
 
Event Description
The balloon catheter was inserted while attached to the balloon pump, everything appeared to be okay. The patient's anatomy was tortuous and a longer than normal sheath was necessary. The augmentation was initially ok but then it appeared low. It was determined that there was a problem with the pressure bag, it was changed out and then the augmentation appeared to be okay again. After about 15 minutes the pump stopped and alarmed, "check iab catheter. " the clinicians checked all connections, checked for blood in the tubing, checked the position of the catheter, and even asked the md to ensure that the catheter was properly positioned. The patient's condition started to deteriorate during this time. The clinicians double checked everything in the help menu on the balloon pump and attempted to restart the pump and received another message, "check iab catheter. " the check iab catheter alarm could not be resolved and the decision was made to put the patient on the impella rather than another iab/pump. The patient was coding when they first had him on the impella but then after an hour he died and the iab was discarded.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSENSATION 7FR 34CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP.
14 philips parkway
montvale NJ 07645
MDR Report Key5742650
MDR Text Key105938708
Report Number2248146-2016-00052
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K041281
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0684-00-9992
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received05/27/2016
Was Device Evaluated by Manufacturer? No Answer Provided
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: 06/22/2016 Patient Sequence Number: 1
-
-