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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL FEMORAL 55CM KIT FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CASHEL FEMORAL 55CM KIT FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number 466F230AF
Device Problems Filter (816); Fracture (1260); Difficult to Remove (1528); Retraction Problem (1536); Failure to Align (2522)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/25/2017
Event Type  Injury  
Manufacturer Narrative

The product was not returned for analysis. Manufacturing record (dhr) review was conducted and the product met quality requirements for product acceptance per the applicable manufacturing quality plan. Additional information will be submitted within 30 days upon receipt.

 
Event Description

The report received indicated that the physician implanted a 55 cm. Femoral optease inferior vena cava (ivc) filter via the femoral approach. Upon viewing the angiogram, the ivc filter was placed well below both rentals and seemed well opposed to the ivc walls and not damaged. Thirteen (13) days after the filter implantation, the physician attempted to retrieve the filter but was not successful. The physician was never able to hook the filter with the snare. After reviewing the angiogram, the filter appeared to be tilted forward, elongated, and possibly fractured. The filter remains implanted. The patient is very large in size. Additional information received indicated that there were no reported product issues noted with the filter prior to the attempted retrieval. The reported product issues of: possible filter fracture, tilt, and elongation were noted after the attempted retrieval attempt. No additional information (such as contributing factors etc. ) were available regarding the attempted filter retrieval. Regarding the implantation of the filter: the indication for filter insertion was deep vein thrombosis (dvt). The dvt was documented/diagnosed by a duplex venous doppler study of the lower extremities. The patient has a history of dvt and coumadin usage. There was no thrombus present at the delivery site. The ivc was reported to be of normal size and shape. No measurement of the ivc was done, visualization of the ivc was done via angiography. There were there no reported peri-procedural or post-procedural complications. There were no reported delivery problems. The filter was not ever in an acute or sharp bend in the delivery tube while it was out of the storage tube. The filter was placed in the ivc below/under the renal arteries. There was no associated filter migration. No additional information is available.

 
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Brand NameFEMORAL 55CM KIT
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel co., tipperary
EI
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel co., tipperary
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key6967884
MDR Text Key89919722
Report Number9616099-2017-01521
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK140286
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/27/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/22/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2019
Device Catalogue Number466F230AF
Device LOT Number17456734
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date09/27/2017
Event Location No Information
Date Manufacturer Received10/23/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/30/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/22/2017 Patient Sequence Number: 1
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