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Adverse Event Report

DATASCOPE CORP./COLLAGEN PRODUCTS VASOSEAL ES EXTRAVASCULAR SECURITY DEVICE   back to search results
Catalog Number 76000
Device Problem Component(s), detachment of
Event Date 08/05/2002
Event Type  Malfunction  
Event Description

The customer reported that following a diagnostic catheterization procedure in 2002, an attempt was made to deploy a vasoseal es. When locating the artery, the operator pulled the locator back and observed that the yellow line was visible, so the j segment was retracted and the locator advanced again to the green line. The operator pulled the locator back and the yellow line was visible again. Another attempt was made, but the yellow line was still visible so the procedure was aborted. When the locator was removed, it was noted that the j segment was missing. The j segment was observed x-ray. No further information was reported.

 
Manufacturer Narrative

A supplemental medwatch report will be submitted upon completion of the product evaluation.

 
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Brand NameVASOSEAL ES
Type of DeviceEXTRAVASCULAR SECURITY DEVICE
Baseline Brand NameVASOSEAL ES
Baseline Generic NameEXTRAVASCULAR SECURITY DEVICE
Baseline Catalogue Number76000
Baseline Device FamilyVASO 2
Baseline Device 510(K) Number
Baseline Device PMA NumberP920004
Baseline Shelf Life Information
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)24
Date First Marketed01/22/1999
Manufacturer (Section F)
DATASCOPE CORP./COLLAGEN PRODUCTS
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer (Section D)
DATASCOPE CORP./COLLAGEN PRODUCTS
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer Contact
laurie bonilla
1300 macarthur blvd.
mahwah , NJ 07430
(201) 995 -8775
Device Event Key403288
MDR Report Key414249
Event Key391703
Report Number9681824-2002-00074
Device Sequence Number1
Product CodeMGB
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 08/05/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/30/2002
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number76000
Device LOT Number04152741
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/19/2002
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/05/2002
Device Ageunknown
Event Location Hospital
Date Manufacturer Received08/05/2002
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device? Unknown
Type of Device Usage Initial

Database last updated on February 28, 2009

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