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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 Difficult or Delayed Positioning (1157)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/24/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Catalog #: unknown but referred to as a cook günther tulip filter. Expiration date: unknown as lot # is unknown. Since catalog# is unknown the 510(k) could be either k090140, k112119 or k121057. Mfr date unknown as lot # is unknown. Summary of investigational findings: no image provided and no product returned and no conclusion can be drawn based on the incomplete information provided concerning the reported difficult advancement of the introducer sheath. However, patient's anatomy may have been a contributing factor since reported that "small vessels and scoliosis which caused the ivc to be severely bent causing the difficulty to maneuver and advance. " no evidence to suggest that this device was not manufactured according to specifications. Cook medical will continue to monitor for similar events.
 
Event Description
Description of event according to initial reporter: "the physician was having problems. He used a gunther. Removed it, then a celect. Removed it, then another gunther. " updated information received 10oct2016: "the tech only noted that there was difficulty with advancement. The physician confirmed that the patients anatomy was small vessels and had scoliosis which caused the ivc to be severely bent causing the difficulty to maneuver and advance. The physician confirmed there was no issue with the product however with maneuvering through patient anatomy. " patient outcome: unknown as information was not provided.
 
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Brand NameUNKNOWN
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
4632 bjaeverskov
DA
Manufacturer Contact
marianne hoey
sandet 6
bjaeverskov 4632
DA   4632
56868686
MDR Report Key6335133
MDR Text Key67546945
Report Number3002808486-2017-00351
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 company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/26/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/10/2016
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

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