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Adverse Event Report

DATASCOPE CORP./COLLAGEN PRODUCTS VASOSEAL ES EXTRAVASCULAR SECURITY DEVICE   back to search results
Catalog Number 76000
Event Date 12/29/2000
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

The customer reported that following a diagnostic catheterization procedure on december 2000, a vasoseal es was deployed. Following deployment the bleeding was noted at the puncture site and manual compression was applied. Upon discharge the pt complained of right calf pain. The pt was discharged and during the next six days experienced an increase in the pain in the pt's right calf and walking was painful. 7 days later and ultrasound and angiogram was performed. A popliteal arterial embolism was diagnosed. A thrombectomy of the right popliteal artery was performed on the following day. The pt was discharged 3 days later and no further complications were reported. The pathology results have not come back yet.

 
Manufacturer Narrative

The eval of the event is based on mfg and qc procedures and history of the device related to this event. Based on the commercial experience, the frequency of reported collagen insertions and thrombus is lower than that observed in the clinical studies performed in support of the pre-market approval of the product. Based on the experience with vasoseal, co believes that the risk of collagen insertion can be minimized by explicity following the technique discussed in the vasoseal instructions for use regarding the initial puncture and placement of the vasoseal components.

 
Event Description

After several attempts, datascope has been unable to obtain the specimen pathology results. No further follow-up is anticipated.

 
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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 Key304519
MDR Report Key314877
Event Key296008
Report Number9681824-2001-00018
Device Sequence Number1
Product CodeMGB
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/18/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/07/2001
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number76000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Ageunknown
Event Location Hospital
Date Manufacturer Received01/18/2001
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on December 31, 2008

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