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Adverse Event Report

BARD VASCULAR SYSTEM BARD INTRAAORTIC BALLOON   back to search results
Lot Number FF 71438
Event Date 12/26/1997
Patient Outcome  Required Intervention;
Event Description

Admitted to hospital 12/26/97 with cardiogenic shock, anterior wall mi, acute pulmonary edema. Found to have severe 3 vessel coronary artery occlusive disease. To surgery for emergency cabg x6 and placement of left femoral iabp. As coming off bypass, noted iabp kept beeping a problem. All connections were checked, system was losing its volume. Felt that balloon itself had been injured. It was removed & and put in a new balloon which was done. Had difficulty passing wire, able to dilate area of obstruction and the balloon passed without difficulty. Felt that probably this was a rough area which was original source of injury to original balloon which lead to subsequent leakage.

 
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Brand NameBARD
Type of DeviceINTRAAORTIC 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 01832
Manufacturer (Section D)
BARD VASCULAR SYS DIV/CARDIAC ASSIST PRODUCTS
25 computer dr.
haverhill MA 01832
Device Event Key143560
MDR Report Key147305
Event Key138279
Report Number147305
Device Sequence Number1
Product CodeDSP
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial Report Via 2nd Source,Initial
Report Date 01/02/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/03/1998
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device LOT NumberFF 71438
OTHER Device ID Number9FR. X 40CC.
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/26/1997
Device Ageunknown
Event Location Hospital
Date Report TO Manufacturer01/02/1997
Is the Device an Implant? Yes
Is this an Explanted Device?

Database last updated on February 28, 2009

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