SHIRANUI EX
Report
- Report Number
- 3002808904-2022-00012
- Event Type
- Injury
- Date Received
- September 11, 2022
- Date of Event
- August 25, 2022
- Report Date
- August 25, 2022
- Manufacturer
- KANEKA CORPORATION
- Product Code
- LIT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE ACTUAL DEVICE WAS RETURNED. IT WAS CONFIRMED THAT THE BALLOON WAS RUPTURED AT APPROXIMATELY 42 MM FROM THE TIP OF THE BALLOON. IT WAS CONFIRMED THAT THE TIP OF THE GW LUMEN IN THE BALLOON OF THE PRODUCT HAD BEEN STRETCHED AND RUPTURED. IT WAS CONFIRMED THAT THERE WAS A LONGITUDINAL CRACK MARK IN THE BALLOON PORTION APPROXIMATELY 42-51 MM FROM THE TIP OF THE PRODUCT. IT WAS CONFIRMED THAT THE BALLOON WAS SPLIT AND RUPTURED STARTING FROM THE TIP OF THE LONGITUDINAL CRACK MARK. PROBABLE CAUSE(S) AND OUR COMMENT: IT IS PRESUMED THAT THE BALLOON RUPTURED WHEN IT CAME INTO CONTACT WITH A HARD LESION, AND THE RUPTURED PORTION OF THE BALLOON CAUGHT ON THE SHEATH WHEN IT WAS REMOVED, CAUSING THE BALLOON TO RUPTURE AND THE CATHETER TO BREAK.
SHIRANUI EX IS AN OVER THE WIRE TYPE SEMI-COMPLIANT PTA BALLOON CATHETER COMPATIBLE WITH 0.018 INCH GUIDEWIRE. SHIRANUI EX HAS NO APPROVAL IN USA. HOWEVER, WE INTEND TO REPORT THIS CASE AS THE EVENT OCCURRED ON THE SIMILAR DEVICE FOR " CROSSTELLA OTW" (OTW TYPE PTA BALLOON DILATATION CATHETER,0.018" GUIDEWIRE COMPATIBLE) IN US UNDER 510(K)# K160004." DURING TREATMENT, THE BALLOON RUPTURED AND REMAINED IN THE BODY. A SHEATH WAS INSERTED AND THE RUPTURED BALLOON WAS REMOVED WITH A SNARE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1577933 | SHIRANUI EX | SHIRANUI EX | LIT | KANEKA CORPORATION | SR052422 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Male | Other |