GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
Report
- Report Number
- 1820334-2021-01870
- Event Type
- Malfunction
- Date Received
- July 27, 2021
- Date of Event
- July 12, 2021
- Report Date
- January 24, 2022
- Manufacturer
- COOK INC
- Product Code
- MMX
- UDI-DI
- 10827002132877
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
DESCRIPTION OF EVENT: AS REPORTED, DURING RETRIEVAL OF AN UNKNOWN INFERIOR VENA CAVA FILTER VIA JUGULAR ACCESS, THE INNER AND OUTER SHEATHS OF A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET ACCORDIONED. DURING THE PROCEDURE, A COOK CELECT FILTER WAS SNARED AND PULLED INTO THE COAXIAL SHEATH. AS THE USER ATTEMPTED TO REMOVE THE FILTER WITH THE INNER SHEATH, RESISTANCE WAS ENCOUNTERED, SO THE FILTER WAS UN-SHEATHED AND SUCCESSFULLY CAPTURED AGAIN. THE COAXIAL SYSTEM ACCORDIONED AS THE USER ATTEMPTED TO REMOVE THE FILTER. EVERYTHING WAS REMOVED AS A UNIT, INCLUDING THE FILTER, AND ACCESS TO THE VASCULAR SYSTEM WAS LOST. IT IS UNKNOWN WHEN THE FILTER WAS INITIALLY PLACED. THE ANATOMY WAS NORMAL. PRESSURE WAS HELD AND ACCESS WAS OBTAINED IN THE FEMORAL VEIN FOR IMAGING. THE PATIENT IS REPORTEDLY OKAY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, TWO HOLES WERE FOUND IN THE SHEATH. INVESTIGATION ¿ EVALUATION: A VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, THE INSTRUCTIONS FOR USE, QUALITY CONTROL DATA, AND SPECIFICATIONS. THE BLUE RETRIEVAL SHEATH, THE BLACK RETRIEVAL CATHETER, THE RETRIEVAL LOOP SYSTEM, AND THE CELECT FILTER WERE RETURNED. ON THE BLUE RETRIEVAL SHEATH DENTS WERE NOTED IN THE TIP, AND THE SHEATH HAD CRACKED 55MM FROM THE DISTAL TIP AND HAD A 100MM ACCORDIONED AREA PROXIMAL TO THE CRACK. NO NONCONFORMANCES WERE NOTED ON THE BLACK RETRIEVAL CATHETER, BUT THE FILTER STUCK INSIDE THE WHITE TUOHY-BORST SIDE-ARM ADAPTER ATTACHED TO THE CATHETER HUB AT THE PROXIMAL END. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. BECAUSE THERE ARE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. THE DEVICE IS PROVIDED WITH INSTRUCTIONS FOR USE (IFU) WHICH DESCRIBE HOW TO ADVANCE THE WHITE SIDE-ARM ADAPTER WITH THE COAXIAL RETRIEVAL SYSTEM, WHILE HOLDING THE LOOP AND CLEAR Y-FITTING STEADY TO COLLAPSE THE FILTER. THE IFU ALSO INSTRUCTS HOW TO LOOSEN THE HUB OF THE BLUE OUTER SHEATH AND ADVANCE THE SHEATH FORWARD TO COVER THE WHOLE FILTER AND RETRIEVE THE COMPLETE ASSEMBLY. BASED ON THESE FINDINGS THE EXACT REASON WHY THE FILTER COULD NOT BE RETRIEVED IN THE FIRST PLACE CANNOT BE DETERMINED. THE CRACK IN THE SHEATH WAS LIKELY CAUSED BY A FILTER LEG AND, IF SO, ATTEMPTS MAY HAVE BEEN MADE TO RETRIEVE THE FILTER THROUGH THE SHEATH WITHOUT PROPERLY COLLAPSING THE FILTER WITH THE BLACK RETRIEVAL CATHETER AS SPECIFIED IN THE IFU. AFTER REPORTED RECAPTURE IT IS LIKELY THE FILTER WAS PROPERLY COLLAPSED BUT PULLED BACK ALL THE WAY THROUGH THE BLACK RETRIEVAL CATHETER, THUS ENDING UP ON THE SIDE-ARM ADAPTER. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR 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.
ADDITIONAL INFORMATION WAS RECEIVED 11AUG2021. THE FILTER BEING RETRIEVED AT THE TIME OF THE EVENT WAS A COOK CELECT FILTER. IT IS UNKNOWN WHEN THE FILTER WAS INITIALLY PLACED. THE ANATOMY WAS NORMAL.
THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
PMA/510(K) NUMBER = K181757. DEVICE EVALUATED BY MFG. DEVICE EVALUATION HAS BEGUN; HOWEVER, A CONCLUSION IS NOT YET AVAILABLE. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
AS REPORTED, DURING RETRIEVAL OF AN UNKNOWN INFERIOR VENA CAVA FILTER VIA JUGULAR ACCESS, THE INNER AND OUTER SHEATHS OF A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET ACCORDIONED. DURING THE PROCEDURE, THE FILTER WAS SNARED AND PULLED INTO THE COAXIAL SHEATH. AS THE USER ATTEMPTED TO REMOVE THE FILTER WITH THE INNER SHEATH, RESISTANCE WAS ENCOUNTERED, SO THE FILTER WAS UN-SHEATHED AND SUCCESSFULLY CAPTURED AGAIN. THE COAXIAL SYSTEM ACCORDIONED AS THE USER ATTEMPTED TO REMOVE THE FILTER. EVERYTHING WAS REMOVED AS A UNIT, INCLUDING THE FILTER, AND ACCESS TO THE VASCULAR SYSTEM WAS LOST. PRESSURE WAS HELD AND ACCESS WAS OBTAINED IN THE FEMORAL VEIN FOR IMAGING. THE PATIENT IS REPORTEDLY OKAY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, TWO HOLES WERE FOUND IN THE SHEATH. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1132639 | GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET | MMX DEVICE, PERCUTANEOUS RETRIEVAL | MMX | COOK INC | 13605587 | 10827002132877 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Female |