FDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH U.S. Food and Drug Administration Center for Devices and Radiological Health [Skip navigation]
horizonal rule
Super Search
510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA
CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards
 

 

Adverse Event Report

BARD VASCULAR SYSTEM REDIGUARD IAB CATHETER INTRA-AORTIC BALLOON   back to search results
Catalog Number 060-0257
Event Date 11/24/1996
Event Type  Malfunction  
Event Description

First iab was in pt for 16. 5 hrs to ok out and inserted a second iab. Second iab was in for 81 hrs, both iab had blood in tubing. No other iab was needed. Pt is critical due to illness.

 
Manufacturer Narrative

H-11-all unk info requested but not received. H-11-section f provided by mfr. H-11-section f10 device code 1746 label.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameREDIGUARD IAB CATHETER
Type of DeviceINTRA-AORTIC BALLOON
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
BARD VASCULAR SYSTEM
12 elizabeth dr
chelmsford MA 01824
Manufacturer (Section D)
BARD VASCULAR SYSTEM
12 elizabeth dr
chelmsford MA 01824
Manufacturer (Section G)
LIFESTREAM INTL., INC.
25 computer dr.
haverhill MA 01832
Device Event Key60091
MDR Report Key59671
Event Key56092
Report Number1222008-1996-00095
Device Sequence Number1
Product CodeDSP
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/23/1996,11/26/1996
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/23/1996
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date06/01/1997
Device Catalogue Number060-0257
Device LOT Number508124
OTHER Device ID Number508161
Was Device Available For Evaluation? Device Returned To Manufacturer
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/24/1996
Device Age6 mo
Event Location Hospital
Date Manufacturer Received11/26/1996
Was Device Evaluated By Manufacturer? No
Date Device Manufactured06/01/1996
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on February 28, 2009

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH