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

Catalog Number UNKNOWN

Device Problems Bent (1059); Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Since catalog# is unknown the 510(k) could be either (b)(4).Corrected data compared to maude event report: (b)(4).Date of this report: (b)(6) 2016.Device available for evaluation: no.Investigation is still in progress.

Event Description

Description of event according to complainant: patient requested for the ivc filter to be removed.During the process of removal, one of the small tines bent and then fractured during the procedure.At fluoro the tine was located in the right ventricle.An attempt to snare the tine was unsuccessful.No dysrhythmia.Patient outcome: the patient was discharged home and has not had any complications related to the retained object.

Manufacturer Narrative

Manufacturer ref# (b)(4).Since catalog# is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121629 or k121057.Corrected data compared to maude event report: mw5060396.Report date: 25mar2016.Expiration date: unknown.(b)(4).Summary of investigational findings: no imaging is provided and no product is returned.Therefore, it is not possible to comment on the filter leg, which fractured during the retrieval attempt and located in the right ventricle.Patient is asymptomatic.Filter fracture of the wire is an uncommon, but known risk in relation to filter implant.However, the filter bent and fractured during retrieval and not during the implant period.Unable to determine a root cause for the filter leg to fracture based on the limited information.Lot# and rpn are unknown, but there is no evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism via placement in the vena cava.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to complainant: patient requested for the ivc filter to be removed.During the process of removal, one of the small tines bent and then fractured during the procedure.At fluoro the tine was located in the right ventricle.An attempt to snare the tine was unsuccessful.No dysrhythmia.Patient outcome: the patient was discharged home and has not had any complications related to the retained object.

• 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: 5580342
• MDR Text Key: 43637384
• Report Number: 3002808486-2016-00214
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2016
• 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: 03/28/2016
• 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 Outcome(s): Other