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 Material Rupture (1546)

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

Event Date 01/09/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Similar to device under 510(k) k090140.Summary of investigational findings: the femoral metal part of the femoral introducer was returned.No filter returned.Furthermore, a 90 cm dilator and a flexor sheath are returned, no damages observed on these parts.However, this dilator and flexor sheath are not parts of this device set (igtcfs-65-uni).Visual inspection of the femoral metal introducer shows no signs of damages.According to the description, "the filter support wire pierced the sheath, which leading to the rupture of the sheath." however, it is unknown what exactly happened during procedure and if the filter pierced the sheath.It is not possible to comment on the penetration as sheath and filter were not returned.Furthermore, the approach is unknown based on description and as the returned femoral introducer appears unused.Under normal conditions the sheath is strong enough to accomplish the procedure, but it has been seen before that the sheath may kink if somehow exposed to excessive force because of tortuous anatomy.If the filter is advanced through a kinked sheath, the filter legs may be prone to exceed the sheath wall.No indications 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: during the process of placing the filter, the filter support wire pierced the sheath, which led to the rupture of the sheath.They retrieved the device and replace with a new one.Patient outcome: the patient did not require any additional procedures due to this occurrence.According to the initial reporter, 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: marianne hoey ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 6275212
• MDR Text Key: 65669728
• Report Number: 3002808486-2017-00081
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002213606
• UDI-Public: (01)10827002213606(17)140726(10)E2952993
• 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: 01/10/2013

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: 01/10/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2012
• 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: 67
• Patient Weight: 70