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

Catalog Number UNKNOWN

Device Problem Retraction Problem (1536)

Patient Problem Insufficient Information (4580)

Event Date 08/08/2022

Event Type  Injury  

Event Description

Description of event according to initial reporter: the filter was placed 3 to 4 months ago.They were not able to retrieve filter with a clover snare with standard procedure.They needed to go to a 12 fr angled sheath.They then looped the glide wire through the body of the filter and externalized the glide wire to right side off the wall of the filter.They advanced the 12 fr sheath over the hook of the filter.He applied traction to the externalized glide wire and advanced the 12 fr sheath over the ivc filter completely.He then removed the filter from the ivc.Upon examination of the filter on the table, one secondary leg was detached from the filter.Upon examination, they were missing one of the 8 secondary legs.Upon examination, an x-ray found that the secondary leg looked like it was in the right ventricle.Then, after that , they tried using a 6 fr multipurpose catheter and put two different kinds of snares (one gooseneck, one multi-petal) in but was unsuccessful trying to snare the secondary leg.The patient was discharged.They resumed his anticoagulant.It has not been confirmed if there will be another attempt to retrieve the leg.Additional information received 11aug2022: 2 secondary legs broke off when retrieving, one came out with the sheath other was left in patient, was unsuccessful in trying to snare this 2nd secondary leg.Patient was doing well and discharged same day as procedure with anticoagulants.Patient outcome: the complainant did not report any adverse effects to the patient due to this occurrence.

• 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: 15316001
• MDR Text Key: 298864719
• Report Number: 3005580113-2022-00097
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/29/2022
• Distributor Facility Aware Date: 08/08/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/26/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/29/2022
• 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 Age: 65 YR
• Patient Sex: Male