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 Known Impact Or Consequence To Patient (2692)

Event Date 09/24/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog #: unknown but referred to as a cook günther tulip filter.Expiration date: unknown as lot # is unknown.Since catalog# is unknown the 510(k) could be either k090140, k112119 or k121057.Mfr date unknown as lot # is unknown.Summary of investigational findings: no image provided and no product returned and no conclusion can be drawn based on the incomplete information provided concerning the reported difficult advancement of the introducer sheath.However, patient's anatomy may have been a contributing factor since reported that "small vessels and scoliosis which caused the ivc to be severely bent causing the difficulty to maneuver and advance." 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 physician was having problems.He used a gunther.Removed it, then a celect.Removed it, then another gunther." updated information received 10oct2016: "the tech only noted that there was difficulty with advancement.The physician confirmed that the patients anatomy was small vessels and had scoliosis which caused the ivc to be severely bent causing the difficulty to maneuver and advance.The physician confirmed there was no issue with the product however with maneuvering through patient anatomy." 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: 6335133
• MDR Text Key: 67546945
• Report Number: 3002808486-2017-00351
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• 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: 10/10/2016
• 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