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Adverse Event Report

BARD VASCULAR SYSTEM REDIGUARD IAB CATHETER INTRA-AORTIC BALLOON   back to search results
Catalog Number 060-0608
Event Date 12/22/1996
Event Type  Malfunction  
Manufacturer Narrative

H11: all unk info requested but not received. Section f info provided by mfr.

 
Event Description

Blood was noticed in the iab tubing during a therapy procedure. The iab was removed, no other iab was replaced as therapy was discontinued. Pt is fine.

 
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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 Key65421
MDR Report Key65327
Event Key61394
Report Number1222008-1996-00113
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 01/21/1997,12/24/1996
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/21/1997
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date06/01/1998
Device Catalogue Number060-0608
Device LOT Number508046
OTHER Device ID Number508160
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 Date12/22/1996
Device Age7 mo
Event Location Hospital
Date Manufacturer Received12/24/1996
Was Device Evaluated By Manufacturer? Yes
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

Patient TREATMENT DATA
Date Received: 01/21/1997 Patient Sequence Number: 1
#TreatmentTreatment Date
1,ST JUDE MEDICAL IABP 700,
2,700.,

Database last updated on February 28, 2009

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