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Adverse Event Report

C.R. BARD, INC. BARD VASCULAR SYSTEMS DIV. BARD INTRA AORTIC BALLOON CATHETER   back to search results
Event Date 04/09/1997
Patient Outcome  Required Intervention;
Event Description

The pt was scheduled for a coronary artery bypass graft. An intra-aortic balloon catheter had been placed by the cath lab. It developed a leak after the pt was back in her room. It was removed without incident. Pt had the bypass procedure as scheduled. There was no injury to the pt.

 
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Brand NameBARD
Type of DeviceINTRA AORTIC BALLOON CATHETER
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
C.R. BARD, INC. BARD VASCULAR SYSTEMS DIV.
25 computer dr.
haverhill MA 01832
Manufacturer (Section D)
C.R. BARD, INC. BARD VASCULAR SYSTEMS DIV.
25 computer dr.
haverhill MA 01832
Device Event Key104610
MDR Report Key106413
Event Key100028
Report Number106413
Device Sequence Number1
Product CodeDSP
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 04/17/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/02/1997
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/09/1997
Event Location Hospital
Date Report TO Manufacturer04/17/1997
Is the Device an Implant? No
Is this an Explanted Device?

Database last updated on February 28, 2009

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