SHIDEN
Report
- Report Number
- 3002808904-2022-00001
- Event Type
- Injury
- Date Received
- January 6, 2022
- Date of Event
- December 6, 2021
- Report Date
- December 7, 2021
- Manufacturer
- KANEKA CORPORATION
- Product Code
- LIT
- PMA / PMN Number
- K152887
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE CONCERNED DEVICE SUBJECT TO THIS REPORTED EVENT, "SHIDEN", AN RX-TYPE PTA BALLOON CATHETER COMPATIBLE WITH 0.014" GUIDEWIRE (GW), IS NOT DISTRIBUTED IN THE US, HOWEVER, WE INTEND TO REPORT THIS CASE AS THE EVENT OCCURRED ON ONE OF THE SIMILAR DEVICES FOR "CROSPERIO RX PTA BALLOON DILATATION CATHETER" DISTRIBUTED IN THE US UNDER 510(K) # K152887. PLEASE FIND BELOW THE RESULTS OF OUR INVESTIGATION. 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 FOR EVERY PRODUCT, AND THE FINISHED PRODUCT INSPECTIONS ON REPRESENTATIVE SAMPLES BASED ON SAMPLING PLAN. NO NONCONFORMITY OR ABNORMALITY IN THE MANUFACTURING PROCESSES OF THE DEVICE CONCERNED WAS FOUND. THE CONCERNED DEVICE WAS RETURNED AND INVESTIGATED: WE CONFIRMED THAT A LOSS OF ABOUT 5 MM AT THE DISTAL TIP AND ABOUT 17 MM AT THE BALLOON. WE CONFIRMED THAT THE BALLOON PART WAS BROKEN IN THE CIRCUMFERENTIAL DIRECTION. WE SPECULATE THE REPORTED SITUATION AS FOLLOWS: BECAUSE IT IS USED IN CALCIFIED LESIONS, THE RUPTURE OCCURRED BECAUSE THE BALLOON WAS DAMAGED AT THE HARD PART OF THE LESION. FURTHER, THE OPERATION WAS NOT POSSIBLE AT THE LESIONED PART OR THE TIP OF THE COMBINED DEVICE (FOR EXAMPLE, GC), AND WHEN THE CATHETER WAS REMOVED FROM THE STUCKED STATE, THE BALLOON WAS BROKEN BY AN EXCESSIVE TENSILE FORCE. THIS WAS CONSIDERED A MALFUNCTION CAUSED BY THE PROCEDURE. NEITHER THE DHR NOR THE INFORMATION AVAILABLE SUGGESTS A DESIGN OR MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT; THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME.
THE CONCERNED DEVICE SUBJECT TO THIS REPORTED EVENT, "SHIDEN", AN RX-TYPE PTA BALLOON CATHETER COMPATIBLE WITH 0.014" GUIDEWIRE (GW), IS NOT DISTRIBUTED IN THE US, HOWEVER, WE INTEND TO REPORT THIS CASE AS THE EVENT OCCURRED ON ONE OF THE SIMILAR DEVICES FOR "CROSPERIO RX PTA BALLOON DILATATION CATHETER" DISTRIBUTED IN THE US UNDER 510(K) # K152887. PLEASE FIND BELOW THE RESULTS OF OUR INVESTIGATION. 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 FOR EVERY PRODUCT, AND THE FINISHED PRODUCT INSPECTIONS ON REPRESENTATIVE SAMPLES BASED ON SAMPLING PLAN. NO NONCONFORMITY OR ABNORMALITY IN THE MANUFACTURING PROCESSES OF THE DEVICE CONCERNED WAS FOUND. THE CONCERNED DEVICE WAS RETURNED AND INVESTIGATED: WE CONFIRMED THAT A LOSS OF ABOUT 5 MM AT THE DISTAL TIP AND ABOUT 17 MM AT THE BALLOON. WE CONFIRMED THAT THE BALLOON PART WAS BROKEN IN THE CIRCUMFERENTIAL DIRECTION. WE SPECULATE THE REPORTED SITUATION AS FOLLOWS: BECAUSE IT IS USED IN CALCIFIED LESIONS, THE RUPTURE OCCURRED BECAUSE THE BALLOON WAS DAMAGED AT THE HARD PART OF THE LESION. FURTHER, THE OPERATION WAS NOT POSSIBLE AT THE LESIONED PART OR THE TIP OF THE COMBINED DEVICE (FOR EXAMPLE, GC), AND WHEN THE CATHETER WAS REMOVED FROM THE "STUCKED" STATE, THE BALLOON WAS BROKEN BY AN EXCESSIVE TENSILE FORCE. THIS WAS CONSIDERED A MALFUNCTION CAUSED BY THE PROCEDURE. NEITHER THE DHR NOR THE INFORMATION AVAILABLE SUGGESTS A DESIGN OR MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT; THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME.
SHIDEN (6.0MM X 20MM) WAS INFLATED FOR THE STENOTIC LESION WITH SEVERE CALCIFIED, HOWEVER THE BALLOON WAS RUPTURED. THEN THE BALLOON WAS CAUGHT ON THE LESION, AND THE BALLOON WAS BROKEN WHEN IT WAS PULLED OUT. THE BROKEN FRAGMENT COULD NOT BE PULL OUT BY THE SNARE. THE BROKEN FRAGMENT WAS LEFT IN THE PATIENT AND WAS TACKLED TO THE VESSEL WALL WITH A STENT.
SHIDEN (6.0MM X 20MM) WAS INFLATED FOR THE STENOTIC LESION WITH SEVERE CALCIFIED, HOWEVER THE BALLOON WAS RUPTURED. THEN THE BALLOON WAS CAUGHT ON THE LESION, AND THE BALLOON WAS BROKEN WHEN IT WAS PULLED OUT. THE BROKEN FRAGMENT COULD NOT BE PULL OUT BY THE SNARE. THE BROKEN FRAGMENT WAS LEFT IN THE PATIENT AND WAS TACKLED TO THE VESSEL WALL WITH A STENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 738957 | SHIDEN | PTA BALLOON DILATATION CATHETER | LIT | KANEKA CORPORATION | SR100568 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |