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

Catalog Number IGTCFS-65-UNI-CELECT

Device Problems Kinked (1339); Detachment of Device or Device Component (2907)

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

Event Date 01/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Similar to device under k090140.(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial report: during the procedure, the user found that the joint (fitting (hub) of the distal tip of sheath fell off during the process of advancing the filter.So the filter could not be delivered to the target sit.Then the physician withdraw the sheath and filter together and replace new one to finish the procedure.The tip which fell off was outside the patient.The user want to withdraw the filter from the sheath , in this process, made a kink and a hole in the sheath.Patient outcome: "a section of the device did not remain inside the patient¿s body.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.".

Manufacturer Narrative

(b)(4).Summary of investigational findings: complete product returned in original tray.The filter has separated, but is without any damages.The hub had separated from the sheath as reported and approx.15cm of distal tip of sheath was missing - probably cut off - and not returned.The sheath is kinked approx.44cm from the flare, but the reported "hole in the sheath" cannot be located, hence it may have been in the cutting.The femoral introducer has been used, but based on information provided it cannot be determined, why the sheath was cut and why the filter "made a kink and a hole in the sheath" during withdrawal from the sheath.The device is found manufactured according to specifications, but since the fitting was pulled off the sheath, it is suggested that the device was exposed to manipulation beyond its intended design during attempted filter placement.It is noted that the procedure was completed with a replacement device and that the patient did not experience any adverse effects due to this occurrence.No evidence to suggest product was not manufactured to specifications and working as intended.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: during the procedure, the user found that the joint (fitting (hub) of the distal tip of sheath fell off during the process of advancing the filter.So the filter could not be delivered to the target sit.Then the physician withdraw the sheath and filter together and replace new one to finish the procedure.The tip which fell off was outside the patient.The user want to withdraw the filter from the sheath , in this process, made a kink and a hole in the sheath.Patient outcome: "a section of the device did not remain inside the patient¿s body.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: COOK CELECT FEMORAL & JUGULAR 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 ; 56868686
• MDR Report Key: 6291998
• MDR Text Key: 66216898
• Report Number: 3002808486-2017-00285
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002456228
• UDI-Public: (01)00827002456228(17)180202(10)E3413102
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-UNI-CELECT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/11/2017
• Initial Date FDA Received: 02/01/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2016
• 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: 59 YR
• Patient Weight: 65