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

Catalog Number UNKNOWN

Device Problem Retraction Problem (1536)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2021

Event Type  Injury  

Event Description

According to the initial reporter - (b)(6) 2021 - celect filter retrieval.2 physicians already attempted retrieval.(physician) is the third to attempt.The hub-hook was embedded in the wall of the ivc above left renal.Ij access and right groin access.Used bronchial forceps to retrieve filter from the wall.Bronchial forceps through ij to pull filter off of the wall of the ivc.Used a glidewire and angeled catheter from the ij to do the ¿hangman¿ technique and get the filter off the wall.Used bronchial forceps from the groin to get the filter off the wall.Did both hangman technique from above and bronchial forceps from below to dislodge filter and was finally successful.The filter was then turned sideways.(physician) used the bronchial forceps to angel the hook caudal and retrieve the filter from the groin with a large bore 18 fr sheath.Dislodge filter at the same time.From ig used bronchial forceps to retrieve filter again, fractured a primary leg off the of filter.Device only had 7 legs upon retrieving, remaining leg was not found or retrieved.

• 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: 12955184
• MDR Text Key: 287017069
• Report Number: 3005580113-2021-00147
• 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: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: Yes
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/07/2021
• Distributor Facility Aware Date: 11/18/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/01/2021
• 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): Required Intervention