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Adverse Event Report

BARD VASCULAR SYSTEM REDIGUARD IAB CATHETER INTRA AORTIC BALLOON   back to search results
Catalog Number 060-0643
Event Date 03/25/1997
Event Type  Death   Patient Outcome  Death;
Manufacturer Narrative

H-11 all unk info requesting/not rec'd h-11 sect f completed by manufacturer.

 
Event Description

The iab was inserted on 3/25/97. Within 1 hour blood was noted in the tubing and the iab was removed. The surgeon stated that the patient had stalactite in her aorta. The patient was reported to have expired due to illness and not a result of this incident.

 
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Brand NameREDIGUARD IAB CATHETER
Type of DeviceINTRA AORTIC BALLOON
Baseline Brand NameREDIGUARD IAB CATHETER
Baseline Generic NameINTRA AORTIC BALLOON
Baseline Catalogue Number060-0643
Other Baseline ID Number13FI0069
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
BARD VASCULAR SYSTEM
12 elizabeth drive
chelmsford MA 01824
Manufacturer (Section D)
BARD VASCULAR SYSTEM
12 elizabeth drive
chelmsford MA 01824
Manufacturer (Section G)
LIFESTREAM INTL., INC.
25 computer dr.
haverhill MA 01832
Device Event Key87682
MDR Report Key88651
Event Key83360
Report Number1222008-1997-00057
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 05/02/1997,04/02/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/02/1997
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date11/30/1998
Device Catalogue Number060-0643
Device LOT Number13JG0302
OTHER Device ID Number13KG0011
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 Date03/25/1997
Device Age5 mo
Event Location Hospital
Date Manufacturer Received04/02/1997
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/01/1996
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 January 30, 2009

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