UNKNOWN
Report
- Report Number
- 3002808486-2024-00118
- Event Type
- Malfunction
- Date Received
- June 25, 2024
- Date of Event
- May 1, 2024
- Report Date
- June 25, 2024
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- OTHER
Narratives
MANUFACTURERS REF (B)(4) BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. D4) CATALOG# IS UNKNOWN BUT REFERRED TO AS COOK GUNTHER TULIP FILTER. G4) PMA/510(K) K211874 SUMMARY OF INVESTIGATIONAL FINDINGS: THE SHEATH FROM THE GTRS RETRIEVAL DEVICE SPLIT (B)(4), REF# 1820334-2024-00700) DURING AN UNSUCCESSFUL RETRIEVAL ATTEMPT OF A TULIP FILTER SIX YEARS AFTER PLACEMENT (B)(4), THIS COMPLAINT). THE RETRIEVAL PROCEDURE WAS ABORTED, BUT NO INFORMATION AS TO ANOTHER RETRIEVAL ATTEMPT AND NO INFORMATION AS TO PATIENT HARM. THE TULIP FILTER WAS NOT RETURNED AND WITHOUT THE ACTUAL COMPLAINT DEVICE IT WOULD INAPPROPRIATE TO SPECULATE AT WHAT MAY OR MAY NOT HAVE CAUSED THE DIFFICULTIES IN RETRIEVING THE FILTER. PHYSICIAN PRACTICE GUIDELINES AND PUBLISHED GUIDANCE FROM REGULATORY AGENCIES RECOMMEND THAT PATIENTS WITH INDWELLING FILTERS UNDERGO ROUTINE FOLLOW-UP. THE RISKS/BENEFITS OF FILTER RETRIEVAL SHOULD BE CONSIDERED FOR EACH PATIENT DURING FOLLOW-UP. ONCE PROTECTION FROM PULMONARY EMBOLISM (PE) IS NO LONGER NECESSARY, FILTER RETRIEVAL SHOULD BE CONSIDERED. FILTER RETRIEVAL SHOULD BE ATTEMPTED WHEN FEASIBLE AND CLINICALLY INDICATED. FILTER RETRIEVAL IS A PATIENT-SPECIFIC, CLINICALLY COMPLEX DECISION; THE DECISION TO REMOVE A FILTER SHOULD BE BASED ON EACH PATIENT¿S INDIVIDUAL RISK/BENEFIT PROFILE (E.G., A PATIENT¿S CONTINUED NEED FOR PROTECTION FROM PE COMPARED TO THEIR EXPERIENCE WITH AND (OR) ONGOING RISK OF EXPERIENCING FILTER-RELATED COMPLICATIONS). THE FILTER IS DESIGNED TO BE RETRIEVED WITH THE GÜNTHER TULIP VENA CAVA FILTER RETRIEVAL SET. IT MAY ALSO BE RETRIEVED WITH THE CLOVERSNARE® VASCULAR RETRIEVER. COOK HAS NOT PERFORMED TESTING TO EVALUATE THE SAFETY OR EFFECTIVENESS OF FILTER RETRIEVAL USING OTHER RETRIEVAL SYSTEMS OR TECHNIQUES. THE PUBLISHED CLINICAL LITERATURE INCLUDES DESCRIPTIONS OF ALTERNATIVE TECHNIQUES FOR FILTER RETRIEVAL; USE OF THESE TECHNIQUES VARIES ACCORDING TO PHYSICIAN EXPERIENCE, PATIENT ANATOMY, AND FILTER POSITION. THE SAFETY OR EFFECTIVENESS OF THESE ALTERNATIVE RETRIEVAL TECHNIQUES HAS NOT BEEN ESTABLISHED. FOR ALL RETRIEVABLE IVC FILTERS, RETRIEVAL BECOMES MORE CHALLENGING WITH TIME, AND THIS IS COMMONLY DUE TO ENCAPSULATION OF THE FILTER LEGS OR HOOK (IN A TILTED FILTER) BY TISSUE INGROWTH. COOK WAS UNABLE TO CONDUCT A REVIEW OF THE DEVICE HISTORY RECORD, AS THE LOT NUMBER OF THE COMPLAINT DEVICE WAS NOT PROVIDED FOR THE INVESTIGATION. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A 48-YEAR-OLD FEMALE PATIENT UNDERWENT A TULIP FILTER REMOVAL PROCEDURE THAT WAS PLACED IN 2018 IN WHICH THE GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET, G13287, WAS USED. ACCESS WAS GAINED IN THE RIGHT INTERNAL JUGULAR. THE SHEATH SPLIT WHILE ADVANCING OVER THE SNARED FILTER. ABORTED CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1157229 | UNKNOWN | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Female |