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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number UNKNOWN
Device Problem Insufficient Information (3190)
Patient Problems Pulmonary Embolism (1498); Thrombus (2101); No Information (3190)
Event Type  Injury  
Manufacturer Narrative
Exemption number e2016032. William cook (b)(4) (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer). Manufacturer reference # (b)(4). Name and address for importer site: (b)(4). Corrected data: adverse event to product problem. Serious injury to malfunction. It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating "a venous thrombosis, bilateral pe and unable to be retrieved". Cook will reopen its investigation if further information is received. Filter retrieval is occasionally difficult. This is well-known from published scientific literature where filter retrievals are referred to as simple vs. Complex. Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques. Pe is a known risk in relation to filter implant reported in the published scientific literature. Also, it is reported that the pulmonary embolism in some cases may originate from upper extremities instead of lower extremity veins. With all filters, there is some risk of further pulmonary embolism. No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e. G. Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.
 
Manufacturer Narrative
Manufacturer ref# (b)(4). Catalog#: unknown but referred to as a gunther tulip filter. Since catalog# is unknown the 510(k) could be either k090140, k112119 or k121057. (b)(4). Investigation is still in progress.
 
Event Description
Description according to short form complaint filed: it is alleged that "[pt] received a gunther tulip filter on (b)(6) 2012. " patient outcome: it is alleged that [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
(b)(4). Catalog#: unknown but referred to as a gunther tulip filter. Expiration date: unknown as lot# is unknown. Pma 510(k): since catalog# is unknown the 510(k) could be either k090140, k112119 or k121057. Mfg date: unknown as lot# is unknown. (b)(4). It has not been possible to investigate or evaluate this alleged event based on the limited information provided to date. Cook will reopen its investigation if further information is receiving warranting supplementation in accordance with 21 c. F. R. 803. 56.
 
Event Description
Description according to short form complaint filed: it is alleged that "[pt] received a gunther tulip filter on (b)(6) 2012. " patient outcome: it is alleged that [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
(b)(4). The event is currently under investigation.
 
Event Description
Per additional information provided on 02/13/2017: it is alleged that the device is attributed to a venous thrombosis within left renal vein and suprarenal vana cava, above the filter; bilateral pe, despite the filter. It is reported that the device is unable to be retrieved.
 
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Brand NameUNKNOWN
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
Manufacturer (Section G)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov 4632, IN 47404
8004574500
MDR Report Key6208766
MDR Text Key205086517
Report Number3002808486-2016-01568
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/01/2019
Was Device Evaluated by Manufacturer? No Answer Provided
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: 12/28/2016 Patient Sequence Number: 1
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