• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD TRANS-RAY 7FR. 34CC IAB - JAPAN 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 FAIRFIELD TRANS-RAY 7FR. 34CC IAB - JAPAN SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0513
Device Problems Device Displays Incorrect Message (2591); Calibration Problem (2890)
Patient Problems Calcium Deposits/Calcification (1758); Unspecified Infection (1930)
Event Date 08/28/2017
Event Type  malfunction  
Manufacturer Narrative
10/06/2017 (b)(4): the product was returned with the membrane completely unfolded and blood on the exterior of the catheter. The extender tubing was also returned. One kink was found on the catheter tubing near the y-fitting approximately 76. 2cm from the iab tip. The inner lumen was found to be occluded with dried blood. The occlusion was unable to be cleared. A sensor output test was performed and a pressure reading could not be obtained. The technician then used an optical light to see if there were any breaks in the sensor's optical fiber and a break was observed within the y-fitting. T the optical fiber was found to be broken, confirming the reported problem. It is difficult to determine when or how a break in the fiber optic occurs. However, a kink in the catheter can cause the fiber optic to break resulting in no signal or the inability to calibrate it. 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. Complaint # (b)(4); record # (b)(4).
 
Event Description
After intra-aortic balloon (iab) iab insertion on myocarditis patient. Calibration was not possible due to iab optical sensor alarm. The iab was replaced to continue therapy. There was no injury or harm to the patient. Mild sclerosis, calcification and severe tortuosity were noted in the patient vessel.
 
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
After intra-aortic balloon (iab) iab insertion on myocarditis patient. Calibration was not possible due to iab optical sensor alarm. The iab was replaced to continue therapy. There was no injury or harm to the patient. Mild sclerosis, calcification and severe tortuosity were noted in the patient vessel.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTRANS-RAY 7FR. 34CC IAB - JAPAN
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 Key6872382
MDR Text Key250771367
Report Number2248146-2017-00394
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
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 10/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/17/2019
Device Catalogue Number0684-00-0513
Device Lot Number3000035332
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/08/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received10/04/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/17/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-