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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 Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/12/2021
Event Type  Malfunction  
Manufacturer Narrative

Manufacturer ref# (b)(4). Catalog# is unknown but referred to as cook gunther tulip filter. Pma/510(k): k172557. Investigation is still in progress.

 
Event Description

Description of event according to initial reporter: an unknown filter, either a g52916 igtcfs-65-1-jug-tulip or g52917 igtcfs-65-1-fem-tulip. Also used in the procedure was a g13287 gtrs-200-rb (lot # 10012453) but per the initial reporter, neither they nor the user facility believe the retrieval set contributed to the failure. ((b)(4) reference # 1820334-2021-01855) implant took place at another user facility and the outpatient location was doing the retrieval procedure. During retrieval (patient no longer needed filter), the user did an initial venogram. Looking for tilt and blood clots, etc. Difficult to see any issue with the filter under fluoro, so they proceeded with the case. They realized after retrieval that part of the secondary strut was bent "upwards. " it wasn't attached to the primary strut. When they snared the filter, they snared that piece as well as the filter and that detached piece sheared the inside of the retrieval sheath. User could tell under fluoro that the sheath was sheared, so they had to remove that sheath and use another 10fr sheath. Upon changing out the sheath, procedure proceeded as normal. Access was not lost during the sheath change. All pieces of the product were successfully retrieved from the patient. Additional information received on 20jul2021: it appears on the initial image taken during the retrieval that the secondary strut was no longer attached to the primary strut. We are uncertain if it was technically fractured at this point, it appears to be flipped upwards. When trying to retrieve the filter, the snare was originally stuck on the secondary strut. This secondary strut was not well visualized on live fluoro, but we could tell the snare was around this piece and we couldnt release it. When the snare was advanced around the hook of the filter, we tried to advance the sheath over the filter. This action caused the sheath tear, the secondary strut had significant friction against the inner sheath and this made the sheath deformed. The physician did not feel comfortable removing the filter with the visibly damaged sheath. A new 10fr sheath was opened and exchanged, the filter hook was snared and the filter plus damaged secondary strut were removed in one attempt successfully. Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence. The patient did not require any additional procedures due to this occurrence.

 
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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
lissi walmann
sandet 6
bjaeverskov 4632 
56868686
MDR Report Key12279057
MDR Text Key265214241
Report Number3002808486-2021-01675
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 08/05/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/05/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKNOWN
Device LOT 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 Received07/12/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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