GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
Report
- Report Number
- 1820334-2021-02239
- Event Type
- Injury
- Date Received
- September 29, 2021
- Date of Event
- December 20, 2020
- Report Date
- February 8, 2022
- Manufacturer
- COOK INC
- Product Code
- MMX
- UDI-DI
- 10827002132877
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
EVENT SUMMARY: AS REPORTED, A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET WAS USED DURING RETRIEVAL OF AN UNSPECIFIED INFERIOR VENA CAVA FILTER THAT HAD BEEN IN PLACE FOR TWO WEEKS. THE FILTER BECAME DISLODGED FROM THE RETRIEVAL DEVICE AND LODGED IN THE PULMONARY ARTERY. THE FILTER WAS RETRIEVED AND THE PATIENT WAS DISCHARGED IN GOOD CONDITION. THE PATIENT DID NOT HAVE ANY TORTUOUS OR ABNORMAL ANATOMY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE NEXT DAY. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. INVESTIGATION - EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES AND A VISUAL INSPECTION OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE RETRIEVAL LOOP SYSTEM, THE BLACK RETRIEVAL CATHETER, AND THE BLUE RETRIEVAL SHEATH WERE RETURNED FOR INVESTIGATION. IN THE RETRIEVAL LOOP SYSTEM, THE LOOP WAS STUCK IN HARDENED BLOOD, BUT AFTER SLIGHT MANIPULATION IT WAS MOVEABLE AND COULD BE ADVANCED THROUGH THE LOOP SYSTEM CATHETER. THE BLUE SHEATH WAS ACCORDIONED 43-116MM FROM THE DISTAL TIP, AND A HOLE WAS NOTED 94MM FROM THE DISTAL TIP. IT IS UNKNOWN WHAT CAUSED THE HOLE. THE SHEATH MATERIAL APPEARED MELTED MORE THAN PENETRATED. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. NO RELATED NON-CONFORMANCES WERE RECORDED, AND THERE HAVE BEEN NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THE DEVICE HISTORY RECORD REVIEW PROVIDES OBJECTIVE EVIDENCE THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING DEVICES FROM THE COMPLAINT LOT IN HOUSE OR IN THE FIELD. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO NOTABLE GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THE REPORTED EVENT. SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE DEVICE IS PROVIDED WITH INSTRUCTIONS FOR USE WHICH WARN, ¿EXCESSIVE FORCE SHOULD NOT BE USED TO RETRIEVE THE FILTER.¿ BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT UNINTENDED USER ERROR MAY HAVE CONTRIBUTED TO THE DEVICE FAILURE MODE. IT IS UNKNOWN HOW THE FILTER LODGED IN THE PULMONARY ARTERY, AS THE VESSEL IS NOT IN THE PATH OF THE SHEATH FOR FILTER RETRIEVAL. IT IS POSSIBLE THAT MANIPULATION OF THE DEVICE DURING RETRIEVAL ALLOWED FOR ADVANCEMENT OF THE DEVICE THROUGH THE RIGHT HEART CHAMBERS AND INTO THE PULMONARY ARTERY. COOK WILL CONTINUE MONITORING OF SIMILAR COMPLAINTS AND HAS NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. 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.
H3 (OTHER)(81): DEVICE HAS BEEN RETURNED AND PRELIMINARY EVALUATION HAS BEEN PERFORMED, HOWEVER, OUR INVESTIGATION IS ONGOING AND DEVICE EVALUATION SUMMARY WILL BE INCLUDED IN OUR FOLLOW UP REPORT ONCE OUR INVESTIGATION HAS BEEN COMPLETED. 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. 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.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
ADDITIONAL INFORMATION RECEIVED (B)(6) 2021. THE PATIENT DID NOT HAVE ANY TORTUOUS OR ABNORMAL ANATOMY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE NEXT DAY. NO UNINTENDED SECTION OF THE DEVICE REMINED INSIDE THE PATIENT'S BODY.
PMA/510(K) NUMBER = K181757. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
AS REPORTED, A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET WAS USED DURING RETRIEVAL OF AN UNSPECIFIED INFERIOR VENA CAVA FILTER THAT HAD BEEN IN PLACE FOR TWO WEEKS. THE FILTER BECAME DISLODGED FROM THE RETRIEVAL DEVICE AND LODGED IN THE PULMONARY ARTERY. THE FILTER WAS RETRIEVED AND THE PATIENT WAS DISCHARGED IN GOOD CONDITION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1443648 | GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET | MMX DEVICE, PERCUTANEOUS RETRIEVAL | MMX | COOK INC | 13261003 | 10827002132877 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Female | Required Intervention |