DUO EXTEND VENOUS STENT SYSTEM
Report
- Report Number
- 3017390540-2024-00001
- Event Type
- Malfunction
- Date Received
- July 31, 2024
- Date of Event
- July 12, 2024
- Report Date
- November 20, 2024
- Manufacturer
- VESPER MEDICAL INC.
- Product Code
- QAN
- PMA / PMN Number
- P230021
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK B5: CORRECTIONS WERE MADE TO BETTER CAPTURE THE REPORTED EVENT.
BLOCK A: THE PATIENT'S DOB OR AGE AT TIME OF EVENT, GENDER, SEX, WEIGHT, ETHNICITY, AND RACE ARE UNKNOWN. THIS INFORMATION WAS NOT AVAILABLE FROM THE FACILITY. BLOCKS B6/B7: PATIENT INFORMATION REGARDING RELEVANT TESTS/LABORATORY DATA OR MEDICAL HISTORY ARE UNKNOWN. THIS INFORMATION WAS NOT AVAILABLE FROM THE FACILITY. BLOCKS D9/H3/H6: THE DUO DEVICE WAS RETURNED FOR EVALUATION; HOWEVER, THE DEVICE EVALUATION HAS NOT YET BEGUN, THUS A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.
BLOCK H3: THE DUO DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION FOUND A FRACTURE AT THE OUTER SHEATH AND AXIAL SUPPORT WIRE EXPOSING A SHARP EDGE, 6 INCHES FROM THE DISTAL TIP. THE BRAID REMAINED INTACT MAINTAINING THE INTEGRITY OF THE CATHETER, BUT BUNCHING AND POOR BRAID TERMINATION WAS NOTED AT THE DISTAL END. DURING FUNCTIONAL TESTING OF THE THUMBWHEEL, THE PROXIMAL PORTION OF THE OUTER SHEATH TRANSLATED DISTALLY AND PROXIMALLY, INDICATING THAT THE HANDLE MECHANISM REMAINED FUNCTIONAL. HOWEVER, THE STENT WAS UNABLE TO BE DEPLOYED AND REMAINED WITHIN THE DISTAL SEGMENT OF THE OUTER SHEATH. BLOCK H6: BASED ON THE DEVICE ANALYSIS, THE JAMMED THUMBWHEEL REPORTED BY THE CUSTOMER IS DUE TO THE BINDING OF THE OUTER SHEATH, GIVING THE IMPRESSION THAT THE THUMBWHEEL HAD LOCKED UP, RESULTING IN THE DAMAGE OBSERVED. A LIKELY ROOT CAUSE OF THE OUTER SHEATH BINDING IS COMPONENT VARIATION. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.
TWO DUO EXTEND VENOUS STENT SYSTEMS WERE USED TO EXTEND THERAPY TO THE COMMON FEMORAL VEIN. DURING THE ATTEMPT TO DEPLOY THE FIRST DUO EXTEND STENT, RESISTANCE WAS NOTED AND THE THUMBWHEEL JAMMED ON THE HANDLE. WITH SUBSTANTIAL FORCE APPLIED TO THE THUMBWHEEL, ANOTHER ATTEMPT WAS MADE TO DEPLOY THE STENT BUT WAS UNSUCCESSFUL. THE PHYSICIAN THEN PERFORMED TWO TURNS ON THE THUMBWHEEL, WHICH EVENTUALLY STARTED SPINNING FREELY BUT WAS STILL UNABLE TO DEPLOY THE STENT. AS A RESULT, THE DUO SYSTEM WAS REMOVED FROM THE PATIENT IN ONE PIECE. A PHOTO OBTAINED SHOWS A SEGMENT OF THE DELIVERY SYSTEM OUTER SHEATH FRACTURED BUT THE SYSTEM REMAINED INTACT. THE FRACTURED OUTER SHEATH EXPOSED A SHARP EDGE FROM THE BRAIDED SHAFT (MDR 3017390540-2024-00001). A SECOND DUO SYSTEM WAS OPENED TO CONTINUE THE PROCEDURE. WHEN ATTEMPTING TO DEPLOY THE STENT, SIGNIFICANT RESISTANCE WAS NOTED AND THE THUMBWHEEL JAMMED ON THE HANDLE. THE PHYSICIAN PERFORMED THREE TURNS ON THE THUMBWHEEL WHICH WERE EXTREMELY DIFFICULT AND WAS ABLE TO PARTIALLY DEPLOY THE STENT; HOWEVER, THE THUMBWHEEL COMPLETELY JAMMED UP. THEREFORE, THE HANDLE WAS DISASSEMBLED (OUTSIDE OF THE PATIENT'S BODY ON TABLE) IN ORDER TO USE A PIN-AND-PULL TECHNIQUE TO DEPLOY THE STENT (MDR 3017390540-2024-00002). THE PROCEDURE WAS COMPLETED WITH NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED DUE THE SHARP EDGE OBSERVED. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.
TWO DUO EXTEND VENOUS STENT SYSTEM WERE USED IN A NON-THROMBOTIC PROXIMAL COMMON FEMORAL VEIN. DURING THE ATTEMPT TO DEPLOY THE FIRST DUO SYSTEM, RESISTANCE WAS NOTED AND THE THUMBWHEEL JAMMED ON THE HANDLE. WITH SUBSTANTIAL FORCE APPLIED TO THE THUMBWHEEL, ANOTHER ATTEMPT WAS MADE TO DEPLOY THE STENT BUT WAS UNSUCCESSFUL. THE PHYSICIAN THEN PERFORMED TWO TURNS ON THE THUMBWHEEL, WHICH EVENTUALLY STARTED SPINNING FREELY BUT WAS STILL UNABLE TO DEPLOY. AS A RESULT, THE DUO SYSTEM WAS REMOVED FROM THE PATIENT IN ONE PIECE. A PHOTO OBTAINED SHOWS A SEGMENT OF THE OUTER SHEATH DETACHED BUT REMAINED INTACT TO THE SYSTEM, EXPOSING A SHARP EDGE . A SECOND DUO SYSTEM WAS OPENED TO CONTINUE THE PROCEDURE. WHEN ATTEMPTING TO DEPLOY THE STENT, SIGNIFICANT RESISTANCE WAS NOTED, AND THE THUMBWHEEL JAMMED ON THE HANDLE. THE PHYSICIAN PERFORMED THREE TURNS ON THE THUMBWHEEL WHICH WERE EXTREMELY DIFFICULT AND WAS ABLE TO PARTIALLY DEPLOY THE STENT, HOWEVER, THE THUMBWHEEL COMPLETELY JAMMED UP. THEREFORE, THE HANDLE WAS DISASSEMBLED EXPOSING THE INNER GEARS (OUTSIDE THE PATIENT'S BODY ON TABLE) IN ORDER TO USE THE PIN-AND-PULL TECHNIQUE TO DEPLOY THE STENT (MDR 3017390540-2024-00002). THE PROCEDURE WAS COMPLETED WITH NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED DUE THE SHARP EDGE OBSERVED. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 863324 | DUO EXTEND VENOUS STENT SYSTEM | STENT, ILIAC VEIN | QAN | VESPER MEDICAL INC. | N1201612010120 | 356081 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | BOSTON SCIENTIFIC: 0.035" GUIDE WIRE.| CORDIS: 6F VISTA BRITE GUIDE CATHETER.| TERUMO: 10F INTRODUCER SHEATH. |