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Adverse Event Report

BARD VASCULAR SYSTEM REDIGUARD IAB CATHETER INTRA AORTIC BALLOON   back to search results
Catalog Number 060-0600
Event Date 05/17/1997
Event Type  Malfunction  
Event Description

The iab was inserted without incident. Later on the iabp gave a kinked tubing alarm. Blood was discovered in the tubing. The iab was removed and replaced. The patient is stable.

 
Manufacturer Narrative

H11-all unk info requested not received. H11-sect f completed by manufacturer.

 
Search Alerts/Recalls

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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 Key100273
MDR Report Key101889
Event Key95777
Report Number1222008-1997-00078
Device Sequence Number1
Product CodeDSP
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 06/20/1997,05/19/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/20/1997
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date01/31/1999
Device Catalogue Number060-0600
Device LOT Number13AH0048
OTHER Device ID Number13LG0185
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/30/1997
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/17/1997
Device Age5 mo
Event Location Hospital
Date Manufacturer Received05/19/1997
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/01/1997
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

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