MAUDE Adverse Event Report: WILLIAM COOK EUROPE GUNTHER TULIP JUGULAR & FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-UNI

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/11/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: the complete set is returned - except for the filter.The jugular introducer is unused.The femoral introducer is slightly bent.When pressing the release button, hardened blood was pushed out at the distal end.However, the piston moved freely and no damages were noted anywhere on introducer.It is assumed, that the secondary filter legs were not expanded as well, since filter was removed and "changed another product to finish the procedure." however, since the filter was not returned and no images were provided, it is not possible to determine the root cause for why the "filter was not completely released during use as the primary filter leg was not completely open".No evidence to suggest product was not manufactured to specifications.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: the filter was not completely released during use as the primary leg was not completely open.Changed another product to finish the procedure.Patient outcome: the patient did not require any additional procedures due to this occurrence.The patient did not experience any adverse effects due to this occurrence.

• Brand Name: GUNTHER TULIP JUGULAR & FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; 4632 bjaeverskov; DA
• Manufacturer Contact: sandet 6; bjaeverskov 4632 ; 56868686
• MDR Report Key: 6275549
• MDR Text Key: 65679368
• Report Number: 3002808486-2017-00040
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002213606
• UDI-Public: (01)10827002213606(17)140207(10)E2872038
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/23/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-UNI
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/23/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 72
• Patient Weight: 55