MAUDE Adverse Event Report: WILLIAM COOK EUROPE GÜNTHER TULIP VENA CAVA FILTER JUGULAR APPROACH; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-JP-JUG-TULIP

Device Problems Bent (1059); Difficult or Delayed Positioning (1157)

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

Event Date 12/10/2012

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog# igtcfs-65-jp-jug-tulip.Similar to device under 510(k) (b)(4).(b)(4).Summary of investigational findings: the knob was found bent as reported, but a thorough investigation did not reveal any marks or sign of weakness to the material, which could have caused the incident.Unable to determine reason for the difficulties encountered when attempting to release the filter in the first place and consequently the knob to bend, but excessive tension may have resulted in the deployment difficulties when pressing the release button and consequently pushing it "several times" may have caused the knob to break.Cook medical will continue to monitor for similar events.

Event Description

When the physician was deploying the filter, the metal knob of the delivery system got broken.Though the knob had been broken, the filter could be placed successfully and the procedure was completed.Additional information received 28dec2012: after the sheath system was advanced to the lesion, the filter introducer was advanced through it as labeled.The filter could be advanced and expanded with no problem, but when the physician pushed the metal knob to release the filter, resistance was encountered and it could not be pushed.When the physician pushed it several times, it could be released from the grasping hook and placed in the target lesion.However, it was confirmed that the metal knob had been broken then.Patient outcome: there have been no adverse effects to the patient reported.

• Brand Name: GÜNTHER TULIP VENA CAVA FILTER JUGULAR APPROACH
• Type of Device: DTK 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 Key: 6272073
• MDR Text Key: 65573820
• Report Number: 3002808486-2017-00065
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037731
• UDI-Public: (01)00827002037731(17)150531(10)E2926109
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-JP-JUG-TULIP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2012
• Date Device Manufactured: 05/31/2012
• 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