OHICHO3
Report
- Report Number
- 3002808904-2026-00004
- Event Type
- Injury
- Date Received
- March 18, 2026
- Date of Event
- February 28, 2026
- Report Date
- March 2, 2026
- 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 DEVICE WAS RETURNED IN A HOOP CONTAINER. IT WAS CONFIRMED THAT THE INNER TUBE OF THE DEVICE HAD ELONGATED, AND THAT THE TIP, BALLOON (APPROXIMATELY 8 MM LENGTH), AND ONE RING MARKER WERE MISSING. IT WAS ALSO CONFIRMED THAT THE INNER SHAFT OF THE PROXIMAL BALLOON WAS DEFORMED. ALSO, THERE WAS A LONGITUDINAL CRACK MARK AT THE FRACTURE SITE ON THE PROXIMAL BALLOON OF THE DEVICE. PROBABLE CAUSE(S) AND OUR COMMENT: WE ASSUME THAT THE BALLOON WAS DAMAGED DUE TO SOME EXTERNAL INFLUENCE, BECAME CAUGHT ON THE SHEATH DURING WITHDRAWAL, AND SUBSEQUENTLY FRACTURED AT THE TIP AND BALLOON WHEN PULLED TOWARD THE PROXIMAL SIDE.
OHICHO3 IS AN OTW-TYPE PTA BALLOON CATHETER COMPATIBLE WITH 0.035 INCH GUIDEWIRE. OHICHO3 HAS NO APPROVAL IN USA. HOWEVER, WE INTEND TO REPORT THIS CASE AS THE EVENT OCCURRED ON THE SIMILAR DEVICE FOR "METACROSS OTW" (OTW TYPE PTA BALLOON. DILATATION CATHETER, 0.035" GUIDEWIRE COMPATIBLE) IN US UNDER 510(K)# K152080". THE DEVICE UNDERWENT ITS THIRD EXPANSION AT 22 ATMOSPHERES. DURING THIS PROCESS, THE BALLOON ON THE DEVICE RUPTURED. AFTER THE RUPTURE, AN ATTEMPT WAS MADE TO REMOVE THE DEVICE, BUT IT BROKE, LEAVING FRAGMENTS INSIDE THE BODY; THESE FRAGMENTS WERE SUBSEQUENTLY REMOVED VIA SURGICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 696398 | OHICHO3 | OHICHO3 | LIT | KANEKA CORPORATION | SR024492 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Female | Required Intervention |