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Adverse Event Report

DATASCOPE CORP/COLLAGEN PRODUCTS VASOSEAL VHD VASCULAR HEMOSTASIS DEVICE   back to search results
Catalog Number 75301
Event Date 02/08/2000
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

The customer reported that following a diagnostic catheterization procedure, a vasoseal vhd kit size 1 was deployed. A moderate hematoma was noted in the right groin and scrotum post deployment and add'l manual compression was held at the site. The following day a surgical consult was advised to evaluate coronary disease and the groin site. The pt received two units of blood prior to cabg surgery scheduled for february 10, 2000. The pt's labs on feb 9 showed hgb 7. 6 and hct 21. 9 and a pseudoaneurysm was suspected, but then later ruled out during a surgical exploration of the groin. No further complications were reported.

 
Manufacturer Narrative

The evaluation of the event is based on manufacturing and qc procedures and history of the device related to this event. Hematomas can result if the vasoseal collagen is not placed accurately over the arterial puncture site or if it is displaced following the procedure. However, these complications are not unusual following cardiac catheterization procedures.

 
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Brand NameVASOSEAL VHD
Type of DeviceVASCULAR HEMOSTASIS DEVICE
Baseline Brand NameVASOSEAL VHD
Baseline Generic NameVASCULAR HEMOSTASIS DEVICE
Baseline Catalogue Number75301
Baseline Device FamilyVASO 1
Baseline Device 510(K) Number
Baseline Device PMA NumberP920004
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)24
Date First Marketed09/25/1995
Manufacturer (Section F)
DATASCOPE CORP/COLLAGEN PRODUCTS
14 philips parkway
montvale NJ 07645
Manufacturer (Section D)
DATASCOPE CORP/COLLAGEN PRODUCTS
14 philips parkway
montvale NJ 07645
Manufacturer (Section G)
DATASCOPE CORP./COLLAGEN PRODUCT DIV.
14 phillips parkway
montvale NJ 07645
Manufacturer Contact
laurie bonilla
14 philips parkway
montvale , NJ 07645
(201) 307 -5559
Device Event Key257929
MDR Report Key266434
Event Key249746
Report Number9681824-2000-00044
Device Sequence Number1
Product CodeMGB
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 02/10/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/29/2000
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number75301
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 Received02/10/2000
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/29/2000 Patient Sequence Number: 1
#TreatmentTreatment Date
1 02/10/2000 - 2 UNITS BLOOD ADMINISTERED. 02/10/2000

Database last updated on December 31, 2008

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