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Adverse Event Report

CARDIAC ASSIT A DIV OF BOSTON SCIENTIFIC CORP. SERIES 3001 INTRA-AORTIC BALLOON PUMP   back to search results
Catalog Number 3000
Event Type  Malfunction  
Event Description

An intra-aortic balloon pump's pressure gauge was intermittently losing pressure during counterpulsation. The pt was transferred to another intra-aortic balloon pump without incident. There were no pt complications involved. No further details are available. The bio-med dept. At the user facility evaluated the balloon pump. A small crack was noted in the male elbow of the pressure gauge. The male elbow was replaced and helium valve was changed and the pump functioned as intended and was placed back in service. Follow up indicated bio-med may have inadvertently cracked the male elbow during service to the pump which co believes contributed to this event.

 
Manufacturer Narrative

F1,f2,f3-na. F11. Date mfr forwarded report to fda. Info supplied in section f was completed by the mfr based on info obtained from the user facility. Any info not included in this section or any other section was na at the time of submission of this medwatch report to the fda. (f6,f7,f8,f10,f11,f12 and f13-medwatch software package requires data in fields).

 
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Brand NameSERIES 3001 INTRA-AORTIC BALLOON PUMP
Type of DeviceINTRA-AORTIC BALLOON PUMP
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
CARDIAC ASSIT A DIV OF BOSTON SCIENTIFIC CORP.
135 forbes blvd.
mansfield MA 02048
Manufacturer (Section D)
CARDIAC ASSIT A DIV OF BOSTON SCIENTIFIC CORP.
135 forbes blvd.
mansfield MA 02048
Manufacturer (Section G)
BOSTON SCIENTIFIC CORP.
135 forbes blvd.
mansfield MA 02048
Device Event Key83299
MDR Report Key83996
Event Key79042
Report Number1220076-1997-00025
Device Sequence Number1
Product CodeDSP
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 03/20/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/10/1997
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number3000
Device LOT Number3453
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/10/1997
Device Agena
Event Location Other
Date Manufacturer Received03/20/1997
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/01/1995
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Database last updated on February 28, 2009

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