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Adverse Event Report

DATASCOPE CORP. TRUE SHEATHLESS DL 9.5 FR. 40CC IAB   back to search results
Model Number 0684-00-0369
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Date 07/18/2002
Event Type  Injury   Patient Outcome  Life Threatening;
Event Description

The iab was inserted into the pt at 1:04 a. M. And removed four days later at 9:30 a. M. No second iab was inserted. The iab did not malfunction. The patient had been bleeding - severely and a transfusion was required. Also, the patient had thrombocytopenia, respiratory failure and renal failure related to iab therapy. No iab was returned. Event complications: bleeding-transfusion-thrombocytopenia-resp/renal failure. Pt's current status: expired-rpt'd 6/03.

 
Manufacturer Narrative

The iab was not returned to datascope. The iab did not malfunction.

 
Search Alerts/Recalls

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Brand NameTRUE SHEATHLESS DL 9.5 FR. 40CC IAB
Baseline Brand NameINSERTION KIT
Baseline Generic NameINSERTION KIT
Baseline Catalogue NumberNA
Baseline Model Number0684-00-0369
Baseline Device FamilyCATHETER ACCESSORIES
Baseline Device 510(K) NumberK980780
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)24
Date First Marketed01/01/1981
Manufacturer (Section F)
DATASCOPE CORP.
15 law dr.
fairfield NJ 07004
Manufacturer (Section D)
DATASCOPE CORP.
15 law dr.
fairfield NJ 07004
Manufacturer Contact
whitney torning, director
15 law drive
fairfield , NJ 07004
(973) 244 -6136
Device Event Key459385
MDR Report Key470545
Event Key445972
Report Number2248146-2003-00004
Device Sequence Number1
Product CodeKGZ
Report Source Manufacturer
Source Type User facility
Reporter Occupation UNKNOWN
Remedial Action Other
Type of Report Initial
Report Date 06/05/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/08/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date10/24/2004
Device MODEL Number0684-00-0369
Device Catalogue Number0684-00-0262-01
Device LOT Number1101
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Unknown
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/05/2003
Device Age10 mo
Event Location Hospital
Date Manufacturer Received06/05/2003
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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 January 30, 2009

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