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

Catalog Number UNKNOWN

Device Problems Entrapment of Device (1212); Fracture (1260); Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 11/14/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.Catalog# is unknown but referred to as cook celect filter.Investigation is still in progress.

Event Description

Description of event according to initial reporter: celect ivc filter found to be fractured, with one arm broken off and retained within the filter.Tip was also embedded.Patient had a failed prior attempt at retrieval.Filter was removed with forceps, as was fragment.Patient outcome: unknown.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: a celect filter was found to be fractured with one filter leg broken off and retained within the filter.The tip of the filter was also embedded.The patient had a failed prior attempt at retrieval.Both filter and the broken fragment was removed with forceps.No adverse effects on the patient was reported due to this occurrence.No images were provided for a clinical assessment.The complaint product was not returned for evaluation and no photos of the product are available.A device failure analysis could therefore not be conducted.Furthermore, cook was unable to conduct a review of the device history record, as the lot number of the complaint device was not provided for the investigation.However, there are adequate controls in place to ensure the device was manufactured to specifications.The exact cause for the reported event cannot be established, due to the limited information provided for the complaint investigation.The dwelling time of the filter is unknown.The time between prior attempt of retrieval and removal of filter with forceps are unknown.Fracture of a filter leg may be due to repetitive motion on a filter leg in an unusual, stressed position, such as a filter leg penetrating/perforating the ivc; or a filter leg being caught in a side branch (e.G., a renal vein).Other potential causes of filter fracture may include excessive force or manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Retrieval of a fractured filter or filter fragments (including embolized fragments) using endovascular techniques has been reported.Potential adverse events that may occur include, but are not limited to, the following: filter fracture, filter or filter fragment embolization, trauma to adjacent structures.Cook medical will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 9393543
• MDR Text Key: 168676114
• Report Number: 3002808486-2019-01882
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 88