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

Catalog Number IGTCFS-65-JP-FEM-TULIP

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2012

Event Type  No Answer Provided  

Manufacturer Narrative

(b)(4).Catalog# igtcfs-65-jp-fem-tulip.Similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: the investigation showed that the filter is severely damaged and the legs are pushed towards the filter hook.Without the introducer system it is not possible to investigate the release mechanism.However, it is explained that "the correct position was verified and the user attempted to release the filter from the delivery system by loosening the red hub and withdrawing the pin vise, but the filter would not be released." step 13 in the package insert is not followed, since the physician withdraw the pin vise, and not the red hub until it contacts the pin vise: to release the filter, in one quick controlled motion pull the red hub until it contacts the pin vise.Repositioning of the filter is no longer possible.The filter is now released.Nothing indicates that this device was not manufactured according to specifications and no indication that the device did not function as intended.During manufacturing the device is inspected to current specifications.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: the device was inserted from the right femoral artery.The physician advanced the sheath with following the instruction and made the filter free of the sheath to prepare for release.The correct position was verified and the user attempted to release the filter from the delivery system by loosening the red hub and withdrawing the pin vise, but the filter would not be released.The physician tried to pull back the filter into the sheath, but failed.However, the filter was pulled back forcibly into the sheath, then half of the filter would not be placed in the sheath but stuck out.When the physician attempted to remove the whole device, wire of the filter was caught on the approaching point (under the skin), which brought resistance and made the removal not possible.Moreover, the filter separated not only from the filter introducer but also from the sheath.The filter separated from the delivery system remained half (hook side)-buried in the vessel and four of the filter legs protruded outside the body.The filter was carefully removed by forcep, and new igtcfs-65-jp-fem-tulip was used to complete the procedure.Patient outcome: there has been no patient outcome reported.

• Brand Name: GÜNTHER TULIP VENA CAVA FEMORAL 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: 6272074
• MDR Text Key: 65565590
• Report Number: 3002808486-2017-00036
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037755
• UDI-Public: (01)00827002037755(17)150112(10)E2858720
• 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: 07/25/2012

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-JP-FEM-TULIP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2012
• 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 Outcome(s): Required Intervention