ZELANTEDVT CLOTHUNTER
Report
- Report Number
- 2124215-2024-43159
- Event Type
- Malfunction
- Date Received
- July 18, 2024
- Date of Event
- June 14, 2024
- Report Date
- September 20, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- QEW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
E1 - INITIAL REPORTER FACILITY NAME: (B)(6). DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS RECEIVED FOR PRODUCT ANALYSIS. VISUAL INSPECTION OF THE DEVICE REVEALED MULTIPLE SHAFT KINKS AND AN UNKNOWN NON-BSC GUIDEWIRE STUCK INSIDE THE DEVICE. AN UNKNOWN NON-BSC .035 GUIDEWIRE WAS RECEIVED STUCK INSIDE THE DEVICE. THE DEVICE WAS FLUSHED AND THE GUIDEWIRE WAS OBSERVED TO HAVE A HYDROPHILIC COATING THAT WAS ABLE TO BE REMOVED ONCE PROPERLY LUBRICATED. INSPECTION OF THE RETURNED DEVICE REVEALED MULTIPLE SHAFT KINKS; HOWEVER, THE KINKS DID NOT DISRUPT GUIDEWIRE INSERTION OR REMOVAL. THE COMPLAINT WAS NOT CONFIRMED FOR GUIDEWIRE INSERTION OR REMOVAL ISSUES; HOWEVER, SHAFT DAMAGE WAS CONFIRMED.
E1 - INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. E1 - INITIAL REPORTER ADDRESS 1:(B)(6).
E1 - INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL
IT WAS REPORTED THAT THE GUIDEWIRE WAS STUCK IN THE CATHETER. THE TARGET LESION WAS LOCATED IN THE POPLITEAL AND FEMORAL VEIN. AN ANGIOJET ZELANTE CATHETER WAS SELECTED FOR VENOUS THROMBOSIS REMOVAL PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE WAS STUCK IN THE CATHETER AND COULD NOT BE PULLED OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST-PROCEDURE. IT WAS FURTHER REPORTED THAT THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED POPLITEAL AND FEMORAL VEIN. FURTHERMORE, THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY BY SIMPLY PULLING IT OUT.
IT WAS REPORTED THAT THE GUIDEWIRE WAS STUCK IN THE CATHETER. THE TARGET LESION WAS LOCATED IN THE POPLITEAL AND FEMORAL VEIN. AN ANGIOJET ZELANTE CATHETER WAS SELECTED FOR VENOUS THROMBOSIS REMOVAL PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE WAS STUCK IN THE CATHETER AND COULD NOT BE PULLED OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST-PROCEDURE.
IT WAS REPORTED THAT THE GUIDEWIRE WAS STUCK IN THE CATHETER. THE TARGET LESION WAS LOCATED IN THE POPLITEAL AND FEMORAL VEIN. AN ANGIOJET ZELANTE CATHETER WAS SELECTED FOR VENOUS THROMBOSIS REMOVAL PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE WAS STUCK IN THE CATHETER AND COULD NOT BE PULLED OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST-PROCEDURE. IT WAS FURTHER REPORTED THAT THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED POPLITEAL AND FEMORAL VEIN. FURTHERMORE, THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY BY SIMPLY PULLING IT OUT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1753420 | ZELANTEDVT CLOTHUNTER | PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION | QEW | BOSTON SCIENTIFIC CORPORATION | 45027 | 0033067377 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Female |