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Adverse Event Report

BARD VASCULAR SYSTEM REDIGUARD IAB CATHETER INTRA AORTIC BALLOON   back to search results
Catalog Number UNK539
Event Date 04/04/1998
Event Type  Malfunction  
Event Description

The pt developed trouble shortly after surgery while in the unit. The pt was taken back to surgery where blood was noted in the tubing. The iab shaft was cut in half while removing. No pt injury or further complications occurred. No further details provided.

 
Manufacturer Narrative

Date of this report: 6/12/98. The device was returned cut in half. Therefore, no product identification can be determined.

 
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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 NumberUNK539
Other Baseline ID NumberNI
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 Key162333
MDR Report Key166829
Event Key156753
Report Number1222008-1998-00118
Device Sequence Number1
Product CodeDSP
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/28/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/07/1998
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK539
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/06/1998
Distributor Facility Aware Date04/14/1998
Device Ageunknown
Event Location Hospital
Date Manufacturer Received04/28/1998
Was Device Evaluated By Manufacturer? Yes
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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