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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 0684-00-0283
Event Date 07/17/1997
Event Type  Malfunction  
Event Description

The iab leaked. This was the only info at the time of the rpt. The following was rpt'd to datascope on 9/3/97: the iab was inserted on 7/15/97. On 7/17/97, the iab tubing filled with blood and the pump was placed on standby. The iab was later removed. In addition, the pt expired 10 days later on 7/27/97. The pt death was not iab related. Event complications: unk - rpt'd 6/16/97; none - rpt'd 9/3/97. Pt current status: expired - rpt'd 9/3/97.

 
Manufacturer Narrative

Device label code for f10. Position 1 and 2: 1738. Position 3: 1701. Evaluation: laboratory examination of the returned item revealed no defect. Underwater leak testing revealed no leaks in the iab. Testing for occult blood within the balloon was negative. Probable cause of difficulty: based on the event description and physical evidence, there was no leak in the iab. It is probable that during insertion blood flowed between the folds of the membrane and exited near the catheter-membrane junction, leading to the perception that the balloon had leaked. Co has incorporated this channeling phenomenon in its instructions for use for all stat iabs.

 
Search Alerts/Recalls

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Brand NamePERCOR STAT DL 9.5 FR. 40 CC IAB
Type of DeviceINTRA-AORTIC BALLOON CATHETER
Baseline Brand NameSTAT DL 9.5 FR. 40 CC. IAB WITH ACCESS.-INTERNAT.
Baseline Generic NameINTRA-AORTIC BALLOON CATHETER
Baseline Catalogue Number0684-00-0283
Baseline Model NumberUNK
Baseline Device FamilyINTRA-AORTIC BALLOON CATHETER
Baseline Device 510(K) NumberK980780
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? Yes
Transitional? No
510(K) Exempt? No
Shelf Life(Months)24
Manufacturer (Section F)
DATASCOPE CORP.
15 law drive
fairfield NJ 07004
Manufacturer (Section D)
DATASCOPE CORP.
15 law drive
fairfield NJ 07004
Manufacturer (Section G)
DATASCOPE CORP., CARDIAC ASSIST DIVISION
15 law dr.
fairfield NJ 07004 0011
Manufacturer Contact
whitney torning
15 law drive
fairfield , NJ 07004
(800) 777 -4222 ext 6136
Device Event Key101995
MDR Report Key103664
Event Key97480
Report Number2248146-1997-00670
Device Sequence Number1
Product CodeDSP
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Remedial Action Other
Type of Report Initial,Followup
Report Date 06/16/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/03/1997
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date04/10/1999
Device MODEL Number0684-00-0283
Device Catalogue Number0684-00-0255-01
Device LOT Number4/10/99
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer09/03/1997
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/17/1997
Device Ageunknown
Event Location Hospital
Date Manufacturer Received09/15/1997
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/1997
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on February 28, 2009

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