UNKNOWN
Report
- Report Number
- 3002808486-2016-01108
- Event Type
- Injury
- Date Received
- September 27, 2016
- Report Date
- September 1, 2016
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- OTHER
Narratives
(B)(4). SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374, K090140, K112119, K121057 OR K121629. (B)(4). INVESTIGATION IS STILL IN PROGRESS.
THIS EVENT SUBMITTED TO FDA UNDER MANUFACTURER REPORT #3002808486-2016-01108 WILL BE CLOSED/CANCELLED AS THE PATIENT DID NOT RECEIVED A FILTER MANUFACTURED BY COOK MEDICAL. (B)(4). SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374, K090140, K112119, K121057 OR K121629.. (B)(4). INVESTIGATION IS STILL IN PROGRESS.
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THIS PATIENT HAD A FRACTURED IVC FILTER OF SOME SORT. THE MANUFACTURER OF THE FILTER IS UNKNOWN. THE LEGS OF THE FRACTURED FILTER HAD POTENTIALLY MIGRATED TO THE HEART. UPDATE 12SEP2016: THE PHYSICIAN WILL LET THE REP KNOW IF IT WAS A COOK FILTER UPON RETRIEVAL. PATIENT OUTCOME: THE PATIENT IS IN STABLE CONDITION.
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THIS PATIENT HAD A FRACTURED IVC FILTER OF SOME SORT. THE MANUFACTURER OF THE FILTER IS UNKNOWN. THE LEGS OF THE FRACTURED FILTER HAD POTENTIALLY MIGRATED TO THE HEART. UPDATE 12SEP2016: THE PHYSICIAN WILL LET THE REP KNOW IF IT WAS A COOK FILTER UPON RETRIEVAL. PATIENT OUTCOME: THE PATIENT IS IN STABLE CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 631033 | UNKNOWN | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |