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Adverse Event Report

DATASCOPE CORP./COLLAGEN PRODUCTS VASOSEAL VHD VASCULAR HEMOSTASIS DEVICE   back to search results
Catalog Number 75303
Device Problem Component(s), detachment of
Event Type  Malfunction  
Event Description

The customer reported that during deployment of the vasoseal vhd kit size 3, the sheath separated from its hub. No pt complications were reported.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

During the mfg process, samples are inspected from each lot of vasoseal vhd to assure that there are no deviations from the specs. Co has reviewed the mfg records of this lot of vasoseal vhd. The co's review of these records indicated no deviation from spec for this production lot. The returned sample was evaluated by the co's engineering dept. The sheath and hub were returned and were observed to be separated with two collagen plugs inside the sheath. Two plunger/cartridge assemblies were also returned. The plunger, cartridge, and sheath/hub interface were all within spec. These dimensions were verified with calibrated instruments. The sheath was separated from its hub and a small portion of the sheath material was visible within the hub. The sheath's distal end exhibited a slight distortion and is not totally round. There was no sign of visible kinking between the distal and proximal ends of the sheath. Two collagen plugs were located inside the sheath. Both plugs were temporarily fused together. The probable cause for the failure experienced is that occlusive pressure was applied too close (<3 cm) to the puncture site, which compressed the sheath, trapping the first collagen plug. Upon deploying the second plug, occlusive pressure remained too close and the second plug stopped up against the first plug. Additional force caused the sheath and hub to separate.

 
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Brand NameVASOSEAL VHD
Type of DeviceVASCULAR HEMOSTASIS DEVICE
Baseline Brand NameVASOSEAL VHD
Baseline Generic NameVASCULAR HEMOSTASIS DEVICE
Baseline Catalogue Number75303
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 pkwy
montvale NJ 07645
Manufacturer (Section D)
DATASCOPE CORP./COLLAGEN PRODUCTS
14 philips pkwy
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 Key261730
MDR Report Key270357
Event Key253473
Report Number9681824-2000-00061
Device Sequence Number1
Product CodeMGB
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/23/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/21/2000
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number75303
Device LOT Number02029172
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/24/2000
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Ageunknown
Event Location Hospital
Date Manufacturer Received02/23/2000
Was Device Evaluated By Manufacturer? Yes
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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