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 Problems Positioning Failure (1158); Appropriate Term/Code Not Available (3191)

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

Event Date 04/23/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog #: igtcfs-65-jp-fem-tulip.Similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: no product returned to assist the investigation, why unable to comment on the burr at the tip of the sheath.However, it is suggested, the sheath tip was damaged if advanced after "strong resistance was encountered." under normal conditions the sheath is strong enough to accomplish the produce, but it may be damaged, if exposed to excessive force.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 procedure was conducted as labeled by right femoral approach.When the physician attempted to insert the sheath into the vein, strong resistance was encountered and it could not be inserted.The physician checked the device and confirmed there is a burr on the tip of it.Since there was no stock of igtcfs-65-jp-fem-tulip at the hospital, optease was implanted alternatively and procedure was completed.Patient outcome: no information provided.

• 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: 6299225
• MDR Text Key: 66565690
• Report Number: 3002808486-2017-00214
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037755
• UDI-Public: (01)00827002037755(17)151214(10)E3022523
• 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: 04/25/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-JP-FEM-TULIP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2013
• Date Device Manufactured: 12/14/2012
• 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