• 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 TRANS-RAY 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. - FAIRFIELD TRANS-RAY 7FR. 34CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0513
Device Problems Difficult to Insert (1316); Unraveled Material (1664)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/24/2020
Event Type  malfunction  
Manufacturer Narrative
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. Complaint record id # (b)(4).
 
Event Description
It was reported that while inserting the intra-aortic balloon (iab) through the sheath, the balloon membrane became unfurled and resistance was met. A new iab was inserted successfully. There was no patient harm or adverse event reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTRANS-RAY 7FR. 34CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer (Section G)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
dorota wolpiuk
15 law drive
fairfield, NJ 07004
MDR Report Key11013275
MDR Text Key227199706
Report Number2248146-2020-00667
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0684-00-0513
Device Lot Number3000108624
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/15/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-