MAUDE Adverse Event Report: WILLIAM COOK EUROPE UNKNOWN; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number UNKNOWN

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog # unknown as information was not provided but could be a gunther tulip mreye, gunther tulip vena cava filter, cook celect vena cava filter or cook celect platinum.Since catalog# is unknown the 510(k) could be either k000855, k032426, k061815, k073374, k090140, k112119, k121057 or k121629.(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: the filter was not deploying after the release button was pressed.Eventually the physician was able to deploy the device.Patient outcome: unknown as information was not provided.

Manufacturer Narrative

Manufacturer ref# (b)(4).Catalog # unknown as information was not provided but referred to as a cook celect platinum.The complaint device was not returned, but 10 unopened/unused devices of 6 different lot#'s were returned.(b)(4).Summary of investigational findings: it is assumed that the complaint device is a celect-pt navalign, since the entire returned stock is of that type.However, no imaging is provided and the complaint device is not returned, so it would be inappropriate to speculate on what went wrong.Therefore, the root cause cannot be determined.It is known from the literature that excessive back tension could result in deployment difficulties/failure when pressing the release button.The ifu addresses the issue through the statement "while keeping slight back tension on the introducer, push the release button completely to ensure proper release of the filter" and the warning "excessive tension during deployment may prevent the filter from releasing when the release mechanism is activated".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 filter was not deploying after the release button was pressed.Eventually the physician was able to deploy the device.Patient outcome: unknown as information was not provided.

• Brand Name: UNKNOWN
• 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: 5972543
• MDR Text Key: 55424561
• Report Number: 3002808486-2016-01131
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2016
• Type of Device Usage: Initial
• Patient Sequence Number: 1