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Adverse Event Report

DATASCOPE CORP. PERCOR STAT DL 9.5 FR. 40 CC IAB INTRA-AORTIC BALLOON CATHETER   back to search results
Model Number 0684-00-0269
Event Date 06/03/1997
Event Description

The iab was inserted into the pt's left femoral artery on 5/31/97 because of chest pain with documented three vessel cad. The pt went for cabg x4 on 6/1/97. In the early am on 6/3/97, blood was noted in the tubing from the catheter. The balloon catheter and sheaths were removed percutaneously because of the balloon rupture. Later in the day, the pt required reinsertion of another iab because of hemodynamic instability. (on 6/4/97, datascope received the mandatory medwatch form from the user facility; uf/dist report number: 090010000-1997-0010). (event complications: unknown-reported 6/4/97. (pt's current status: unk-rpt'd 6/4/97.

 
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Brand NamePERCOR STAT DL 9.5 FR. 40 CC IAB
Type of DeviceINTRA-AORTIC BALLOON CATHETER
Baseline Brand NamePERCOR STAT DL 9.5 FR. 40 CC IAB
Baseline Generic NameINTRA-AORTIC BALLOON CATHETER
Baseline Catalogue Number0684-00-0270-01
Baseline Model Number0684-00-0269
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
DATASCOPE CORP.
15 law drive
fairfield NJ 07004
Device Event Key98531
MDR Report Key100012
Event Key94054
Report Number100012
Device Sequence Number1
Product CodeDSP
Report Source User Facility
Reporter Occupation Other
Type of Report Initial,Initial Report Via 2nd Source
Report Date 06/05/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/17/1997
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date02/22/1999
Device MODEL Number0684-00-0269
Device Catalogue Number0684-00-0270-01
Device LOT Number2/22/99
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/03/1997
Device Age3.4 mo
Event Location Hospital
Date Report TO Manufacturer06/04/1997
Is the Device an Implant? No
Is this an Explanted Device?

Database last updated on February 28, 2009

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