UNKNOWN
Report
- Report Number
- 3002808486-2015-00146
- Event Type
- Malfunction
- Date Received
- November 19, 2015
- Report Date
- October 29, 2015
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- PMA / PMN Number
- K090140
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- ATTORNEY
Narratives
(B)(4). CATALOG # UNKNOWN AS INFORMATION WAS NOT PROVIDED BUT REFERRED TO AS A COOK FILTER. EXPIRATION DATE UNKNOWN AS LOT # IS UNKNOWN. AS CATALOG # IS UNKNOWN IT COULD BE EITHER K061815, K073374, K090140, K112119, K121057 OR K121629. UNKNOWN AS LOT # IS UNKNOWN. IT HAS NOT BEEN POSSIBLE TO INVESTIGATE THIS EVENT BASED ON THE LIMITED INFORMATION, AND WE ARE CLOSING THE REPORT UNTIL FURTHER INFORMATION IS RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, THE REPORT WILL BE RE-OPENED FOR FURTHER INVESTIGATION.
(B)(4). CATALOG # UNKNOWN AS INFORMATION WAS NOT PROVIDED BUT REFERRED TO AS A COOK FILTER. AS CATALOG # IS UNKNOWN IT COULD BE EITHER K061815, K073374, K090140, K112119, K121057 OR K121629. (B)(4). INVESTIGATION IN PROGRESS.
(B)(4). CATALOG # UNKNOWN AS INFORMATION WAS NOT PROVIDED BUT REFERRED TO AS A COOK FILTER. AS CATALOG # IS UNKNOWN IT COULD BE EITHER K061815, K073374, K090140, K112119, K121057 OR K121629. (B)4). SUMMARY OF INVESTIGATIONAL FINDINGS: IT HAS NOT BEEN POSSIBLE TO FURTHER INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE VIA THE OPERATIVE NOTE STATING "PT SUFFERS FROM TILT, THE INABILITY TO RETRIEVE THE DEVICE, AND OTHER: EMBEDDED, FILTER ONLY 90% SHEETED UPON RETRIEVAL ATTEMPT." COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56." FILTER TILT IS A KNOWN POTENTIAL COMPLICATION OF VENA CAVA FILTERS. AMONG OTHER CAUSES, FILTER TILT MAY BE ASSOCIATED WITH PLACEMENT IN IVCS WITH DIAMETERS LARGER THAN THOSE SPECIFIED IN THESE INSTRUCTIONS FOR USE; IMPROPER DEPLOYMENT; MANIPULATIONS NEAR AN IMPLANTED FILTER (E.G., A SURGICAL PROCEDURE IN THE VICINITY OF A FILTER) AND (OR) PROCEDURES THAT INVOLVE DEVICES PASSING THROUGH A FILTER, OR A FAILED RETRIEVAL ATTEMPT. EXCESSIVE FILTER TILT MAY RESULT IN LOSS OF FILTER EFFICIENCY. FILTER RETRIEVAL IS OCCASIONALLY DIFFICULT. THIS IS WELL-KNOWN FROM PUBLISHED SCIENTIFIC LITERATURE WHERE FILTER RETRIEVALS ARE REFERRED TO AS SIMPLE VS. COMPLEX. SEVERAL CASE REPORTS PUBLISHED IN SCIENTIFIC LITERATURE DESCRIBE COMPLEX CASES WITH SUCCESSFUL ENDOVASCULAR FILTER RETRIEVALS USING ADDITIONAL, ADVANCED TECHNIQUES. 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 (PE) VIA PLACEMENT IN THE VENA CAVA. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.
(B)(4). EVENT DATE: UNKNOWN AS INFORMATION WAS NOT PROVIDED. DEVICE: UNKNOWN AS INFORMATION WAS NOT PROVIDED. CATALOG # UNKNOWN AS INFORMATION WAS NOT PROVIDED BUT REFERRED TO AS A COOK FILTER. LOT # UNKNOWN AS INFORMATION WAS NOT PROVIDED. EXPIRATION DATE UNKNOWN AS LOT# IS UNKNOWN. CATALOG # IS UNKNOWN IT COULD BE EITHER K061815, K073374, K090140, K112119, K121057 OR K121629. MFR DATE: UNKNOWN AS LOT # IS UNKNOWN. INVESTIGATION IS STILL IN PROGRESS.
DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED A COOK FILTER (TYPE ¿UNKNOWN¿) IN (B)(6) 2013." PATIENT OUTCOME: IT IS ALLEGED THAT [PT] WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.
DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED A COOK FILTER (TYPE ¿UNKNOWN¿) IN (B)(6) 2013". ADDITIONAL INFORMATION RECEIVED JANUARY 30, 2017: IT IS ALLEGED THAT PT SUFFERS FROM TILT, THE INABILITY TO RETRIEVE THE DEVICE, AND OTHER: EMBEDDED, FILTER ONLY 90% SHEETED UPON RETRIEVAL ATTEMPT.
DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED A COOK FILTER (TYPE ¿UNKNOWN¿) IN (B)(6) OF 2013". ADDITIONAL INFORMATION RECEIVED 30JAN2017: IT IS ALLEGED THAT [PT] SUFFERS FROM TILT, THE INABILITY TO RETRIEVE THE DEVICE, AND OTHER: EMBEDDED, FILTER ONLY 90% SHEETED UPON RETRIEVAL ATTEMPT.
DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED A COOK FILTER (TYPE ¿UNKNOWN¿) AT THE (B)(6) HOSPITAL IN (B)(4) IN (B)(6) 2013." PATIENT OUTCOME: IT IS ALLEGED THAT [PT] WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 767907 | UNKNOWN | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening| O |