OHICHO3
Report
- Report Number
- 3002808904-2022-00010
- Event Type
- Injury
- Date Received
- August 30, 2022
- Date of Event
- June 28, 2022
- Report Date
- August 15, 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 DEVICE HISTORY RECORDS (DHR) OF THE DEVICE CONCERNED WAS REVIEWED. THE PRODUCTION LOT, TO WHICH THE DEVICE CONCERNED BELONGS, PASSED ALL IN-PROCESS INSPECTIONS INCLUDING THE SHAFT-PRESSURIZED TEST AND THE BALLOON-WRAPPING TEST FOR EVERY PRODUCT, AND THE FINISHED PRODUCT INSPECTIONS INCLUDING THE SHAFT TENSILE STRENGTH TEST AND THE REPETITIVE BALLOON INFLATION/DEFLATION TEST ON REPRESENTATIVE SAMPLES BASED ON SAMPLING PLAN. NO NONCONFORMITY OR ABNORMALITY IN THE MANUFACTURING PROCESSES OF THE DEVICE CONCERNED WAS FOUND. PROBABLE CAUSE(S) AND OUR COMMENT: IT IS ASSUMED THAT THE BALLOON RUPTURED DUE TO CONTACT WITH A HARD LESION, ETC., AND THAT WHEN THE RUPTURED BALLOON WAS REMOVED, THE BULKY PORTION CAUGHT ON THE SHEATH, ETC., CAUSING DIFFICULTY IN REMOVAL.
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". A BALLOON RUPTURE OCCURRED DURING 3 TO 5 DILATATIONS PER SITE, EACH DILATATION LASTING 60 TO 180 SECONDS AT A PRESSURE OF 22 ATM. ATTEMPTS TO REMOVE THE DEVICE WERE UNSUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 134178 | OHICHO3 | OHICHO3, PRODUCT CODE: LIT | LIT | KANEKA CORPORATION | SR021096 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Male | Other |