SENRI
Report
- Report Number
- 3002808904-2021-00011
- Event Type
- Malfunction
- Date Received
- November 7, 2021
- Date of Event
- September 30, 2021
- Report Date
- October 15, 2021
- Manufacturer
- KANEKA CORPORATION
- Product Code
- LIT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE CONCERNED DEVICE "SENRI" IS A RAPID-EXCHANGE (RX) TYPE SEMI-COMPLIANT PTA BALLOON DILATATION CATHETER COMPATIBLE TO 0.018" GUIDEWIRE (GW). "SENRI" HAS NO APPROVAL IN THE US, HOWEVER, WE WILL REPORT THIS CASE AS AN INCIDENT OCCURRED ON A SIMILAR DEVICE FOR "CROSSTELLA RX" (A RX-TYPE PTA BALLOON DILATATION CATHETER, COMPATIBLE TO 0.018" GW) THAT IS DISTRIBUTED IN THE US UNDER 510(K) # K152873. 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. WE ASSUME THE CAUSE OF THIS AS FOLLOWS: FACTORS THAT MAY CONTRIBUTE TO THE BALLOON/SHAFT BREAKAGE INCLUDE, BUT ARE NOT LIMITED TO, DURING WITHDRAWAL OF THE CATHETER SHAFT AFTER DILATING THE BALLOON, THE DISTAL PART WAS STUCK AT THE SEVERELY CALCIFIED LESIONS, AND THEN BROKEN DUE TO EXCESSIVE PULLING FORCE WAS LOADED, WHICH WE ASSUME TO BE DUE TO PROCEDURE AND/OR PATIENT'S VESSEL CONDITION. WE WILL CONDUCT DEVICE EVALUATION WHEN THE CONCERNED ACTUAL DEVICE IS RETURNED TO FINALIZE INVESTIGATION OF THE EVENT. IN THE INSTRUCTIONS FOR USE OF SENRI (3898-5) , WE STATE THE POTENTIAL OF KNOWN RISK AS BELOW; [PRECAUTIONS DURING USAGE] [IMPORTANT BASIC PRECAUTIONS] 3. THIS CATHETER SHOULD BE USED ONLY BY PHYSICIANS SKILLED IN PERCUTANEOUS VASCULAR THERAPY. 6. THE PHYSICIAN IN CHARGE OF THE PROCEDURE SHOULD DETERMINE THE DURATION AND NUMBER OF BALLOON INFLATIONS BASED ON HIS/HER PAST EXPERIENCES. 10. ALWAYS INFLATE THE BALLOON WHILE OBSERVING ITS INFLATION STATE UNDER FLUOROSCOPY. INFLATE THE BALLOON CAREFULLY WHILE VERIFYING ITS MOVEMENT WITH THE RADIOPAQUE MARKERS. IF ANY ABNORMALITY IS FOUND SUCH AS A LITTLE RESISTANCE, IMMOVABLE CATHETER DURING MANIPULATION, OR KINKED DISTAL TIP OF THE GUIDEWIRE, THE PROCEDURE SHOULD BE DISCONTINUED IMMEDIATELY AND THIS CATHETER SHOULD BE REMOVED SLOWLY TOGETHER WITH THE GUIDEWIRE. 15. DO NOT INSERT OR WITHDRAW THIS CATHETER FORCEFULLY. (DOING SO MAY CAUSE THE CATHETER TO KINK IN THE HIGHLY TORTUOUS PORTION OF THE BLOOD VESSEL.)
THE CONCERNED DEVICE "SENRI" IS A RAPID-EXCHANGE (RX) TYPE SEMI-COMPLIANT PTA BALLOON DILATATION CATHETER COMPATIBLE TO 0.018" GUIDEWIRE (GW). "SENRI" HAS NO APPROVAL IN THE US, HOWEVER, WE WILL REPORT THIS CASE AS AN INCIDENT OCCURRED ON A SIMILAR DEVICE FOR "CROSSTELLA RX" (A RX-TYPE PTA BALLOON DILATATION CATHETER, COMPATIBLE TO 0.018" GW) THAT IS DISTRIBUTED IN THE US UNDER 510(K) # K152873. 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. RESULTS OF THE INVESTIGATION ON RETURNED CONCERNED DEVICE: THE BALLOON WAS BROKEN AT 55MM FROM THE PROXIMAL PART OF THE BALLOON. ALSO, THE 270MM OF INNER SHAFT (GW LUMEN) WAS NOT RETURNED. THE BALLOON HAD SCRATCH MARKS VERTICALLY, AND CREASED OVER ENTIRE LENGTH. THE DISTAL SHAFT WAS DEFORMED. WE ASSUME THE CAUSE OF THIS AS FOLLOWS: FACTORS THAT MAY CONTRIBUTE TO THE BALLOON/SHAFT BREAKAGE INCLUDE, BUT ARE NOT LIMITED TO, DURING WITHDRAWAL OF THE CATHETER SHAFT AFTER DILATING THE BALLOON, THE DISTAL PART WAS STUCK AT THE SEVERELY CALCIFIED LESIONS, AND THEN BROKE DUE TO EXCESSIVE PULLING FORCE LOADED, WHICH WE ASSUME TO BE DUE TO PROCEDURE AND/OR PATIENT'S VESSEL CONDITION. WE ESTIMATED THAT APPROXIMATELY 95MM OF THE BALLOON WAS LEFT IN THE PATIENT BODY. IN THE INSTRUCTIONS FOR USE OF SENRI (3898-5) , WE STATE THE POTENTIAL OF KNOWN RISK AS BELOW; [PRECAUTIONS DURING USAGE] [IMPORTANT BASIC PRECAUTIONS]. THIS CATHETER SHOULD BE USED ONLY BY PHYSICIANS SKILLED IN PERCUTANEOUS VASCULAR THERAPY. THE PHYSICIAN IN CHARGE OF THE PROCEDURE SHOULD DETERMINE THE DURATION AND NUMBER OF BALLOON INFLATIONS BASED ON HIS/HER PAST EXPERIENCES. ALWAYS INFLATE THE BALLOON WHILE OBSERVING ITS INFLATION STATE UNDER FLUOROSCOPY. INFLATE THE BALLOON CAREFULLY WHILE VERIFYING ITS MOVEMENT WITH THE RADIOPAQUE MARKERS. IF ANY ABNORMALITY IS FOUND SUCH AS A LITTLE RESISTANCE, IMMOVABLE CATHETER DURING MANIPULATION, OR KINKED DISTAL TIP OF THE GUIDEWIRE, THE PROCEDURE SHOULD BE DISCONTINUED IMMEDIATELY AND THIS CATHETER SHOULD BE REMOVED SLOWLY TOGETHER WITH THE GUIDEWIRE. DO NOT INSERT OR WITHDRAW THIS CATHETER FORCEFULLY. (DOING SO MAY CAUSE THE CATHETER TO KINK IN THE HIGHLY TORTUOUS PORTION OF THE BLOOD VESSEL).
PROCEDURE WAS PERFORMED ON THEATRE TABLE IN MAIN OPERATING THEATRE. FOLLOWING ENDARTERECTOMY OF THE SFA AN ANGIOGRAM DEMONSTRATED SEVERE CALCIFIC OCCLUSIVE DISEASE OF THE SFA AND POPLITEAL ARTERIES. VERY DIFFICULT PROCEDURE DUE TO THE DEGREE OF CALCIFICATION. IT WAS A DIFFICULT SUB-INTIMAL CROSSING OF THE OCCLUSIONS. ANGIOPLASTY PERFORMED WITH 5MM X 15CM SENRI BALLOON. THE BALLOON BURST DUE TO THE CALCIFICATION AT THE PROXIMAL TO MID SFA. THE SENRI BALLOON BURST CIRCUMFERENTIALLY AND IT WAS NOT POSSIBLE TO RETRIEVE THE DISTAL TIP OF THE BALLOON WITH A SNARE DESPITE MULTIPLE ATTEMPTS. THE DISTAL TIP OF THE SENRI BALLOON WAS RETAINED IN THE ARTERY BUT THIS DID NOT CAUSE ANY CLINICAL PROBLEM AS THE LENGTH OF THE SFA WAS THEN STENTED WITH TWO 6MM STENTS AND MORE DISTALLY WITH A 5MM STENT INTO THE ABOVE-KNEE POPLITEAL ARTERY. THIS OPENED FLOW INTO THE TRIFURCATION. THE PATIENTS FOOT WAS WARM AND PINK AT THE END OF THE PROCEDURE AND THE NEXT DAY TOO. CLINICIAN SAID OVERALL IT WAS A GOOD RESULT.
PROCEDURE WAS PERFORMED ON THEATRE TABLE IN MAIN OPERATING THEATRE. FOLLOWING ENDARTERECTOMY OF THE SFA AN ANGIOGRAM DEMONSTRATED SEVERE CALCIFIC OCCLUSIVE DISEASE OF THE SFA AND POPLITEAL ARTERIES. VERY DIFFICULT PROCEDURE DUE TO THE DEGREE OF CALCIFICATION. IT WAS A DIFFICULT SUB-INTIMAL CROSSING OF THE OCCLUSIONS. ANGIOPLASTY PERFORMED WITH 5MM X 15CM SENRI BALLOON. THE BALLOON BURST DUE TO THE CALCIFICATION AT THE PROXIMAL TO MID SFA. THE SENRI BALLOON BURST CIRCUMFERENTIALLY AND IT WAS NOT POSSIBLE TO RETRIEVE THE DISTAL TIP OF THE BALLOON WITH A SNARE DESPITE MULTIPLE ATTEMPTS. THE DISTAL TIP OF THE SENRI BALLOON WAS RETAINED IN THE ARTERY BUT THIS DID NOT CAUSE ANY CLINICAL PROBLEM AS THE LENGTH OF THE SFA WAS THEN STENTED WITH TWO 6MM STENTS AND MORE DISTALLY WITH A 5MM STENT INTO THE ABOVE-KNEE POPLITEAL ARTERY. THIS OPENED FLOW INTO THE TRIFURCATION. THE PATIENTS FOOT WAS WARM AND PINK AT THE END OF THE PROCEDURE AND THE NEXT DAY TOO. CLINICIAN SAID OVERALL IT WAS A GOOD RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1661396 | SENRI | SENRI PTA BALLOON DILATATION CATHETER | LIT | KANEKA CORPORATION | SR071362 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Male | Other |