RUNTHROUGH NS
Report
- Report Number
- 9681834-2018-00002
- Event Type
- Injury
- Date Received
- January 30, 2018
- Date of Event
- January 9, 2018
- Report Date
- January 30, 2018
- Manufacturer
- TERUMO CORPORATION, ASHITAKA
- Product Code
- DQX
- PMA / PMN Number
- K063695
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
D6: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D7: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED G5: 510K - K080563 THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION UPON RECEIPT FOUND THAT THE NITI CORE WIRE AND COIL HAD BEEN FRACTURED AT THE DISTAL END. THE LENGTH OF THE NITI CORE WIRE LOCATED INSIDE THE COIL WAS MEASURED AND WAS FOUND TO BE SHORTER THAN THE CURRENT PRODUCT SAMPLE BY APPROXIMATELY 40MM (THE SEGMENT 40MM IN LENGTH IS MISSING). THE OUTSIDE DIAMETER OF THE NITI CORE WIRE WAS MEASURED ON THE SEGMENT ADJACENT TO THE FRACTURED END AND CONFIRMED TO BE EQUIVALENT TO THAT OF THE CURRENT PRODUCT SAMPLE. MEASUREMENTS RESULTS FOR THE NITI CORE WIRE ARE AS FOLLOWS. LENGTH OF THE PORTION LOCATED INSIDE THE COIL OF THE ACTUAL DEVICE MEASURED APPROXIMATELY 210MM. MEASUREMENTS OF A CURRENT PRODUCT SAMPLE MEASURED APPROXIMATELY 250MM. OUTSIDE DIAMETER OF THE ACTUAL DEVICE MEASURED APPROXIMATELY 160 MM. OUTSIDE DIAMETER OF A CURRENT PRODUCT SAMPLE MEASURED APPROXIMATELY 160 MM. MAGNIFYING INSPECTION OF THE COIL FOUND THAT IT HAD BEEN UNRAVELED ON THE SEGMENT FROM THE DISTAL FRACTURE END TO THE JOINT OF THE STAINLESS STEEL COIL AND NITI CORE WIRE. IT IS LIKELY THAT THE TOTAL LENGTH OF THE PLATINUM COIL SEGMENT (=RADIOPAQUE MARKER) AND A PARTIAL SEGMENT OF THE STAINLESS STEEL COIL WERE SEPARATED AND MISSING FROM THE MAIN BODY OF THE DEVICE. UNRAVELING OCCURRED ON THE COIL PREVENTED THE LENGTH OF THE MISSING PORTION OF THE COIL FROM BEING DETERMINED. ELECTRON MICROSCOPIC INSPECTION OF THE FRACTURE OF THE NITI CORE WIRE REVEALED THAT THE FRACTURE CROSS-SECTION WAS ALMOST FLAT WITH THE GENERATION OF THE DIMPLE PATTERN ON 3/4 OF THE TOTAL AREA AND RADIAL PATTERN ON THE 1/4 OF THE TOTAL AREA. THERE WAS NO DEFORMATION INTO A FLEXED SHAPE OR DIMINISHMENT IN THE OUTSIDE DIAMETER TOWARD THE FRACTURE END. FUNCTIONAL TESTING WAS CONDUCTED. A CURRENT RUNTHROUGH NS SAMPLE WAS INSERTED INTO A PHANTOM BLOOD VESSEL AND ONE POINT ON THE STAINLESS STEEL SEGMENT WAS TRAPPED WITH FORCEPS OVER THE PHANTOM BLOOD VESSEL. (SIMULATION OF THE SITUATION OF A DEVICE BEING TRAPPED IN A STENOSED LESION). A. SUBSEQUENTLY THE RUNTHROUGH NS WAS SUBJECTED TO PULLING FORCE TILL NITI CORE WIRE BECAME FRACTURED. B. SUBSEQUENTLY THE RUNTHROUGH NS WAS SUBJECTED TO REPETITIVE BENDING FORCE TILL NITI CORE WIRE BECAME FRACTURED. C. SUBSEQUENTLY THE RUNTHROUGH NS WAS SUBJECTED TO PULLING FORCE IN THE STATE OF THE SHAFT BEING FORMED INTO A LOOP SHAPE TILL NITI CORE WIRE BECAME FRACTURED. AFTER THE NITI CORE WIRE BECAME FRACTURED, THE RUNTHROUGH NS WAS FURTHER PULLED. AS THE RESULT, IN ALL THE CASES OF A, B AND C, THE STAINLESS STEEL COIL BECAME UNRAVELED AND FINALLY FRACTURED. AFTER THE ABOVE TESTS, EACH FRACTURE CROSS-SECTION WAS INSPECTED UNDER MAGNIFICATION AND ELECTRON MICROSCOPE. A. PULLING FORCE: THE DISTAL SEGMENT WAS NOTED TO HAVE BEEN DIMINISHED TOWARD THE FRACTURE END. THE STATE OF THE FRACTURE WAS FOUND TO DIFFER FROM THAT OF THE ACTUAL DEVICE. B. REPETITIVE BENDING FORCE: THE RUNTHROUGH NS SAMPLE WAS TRAPPED ON THE STAINLESS STEEL SEGMENT AT APPROXIMATELY 35MM FROM THE DISTAL END OF THE DEVICE AT THE OSTIAL OF THE BRANCH VESSEL SIDE OF THE BIFURCATION. IN THIS STATE THE RUNTHROUGH NS WAS PUSHED FORWARD AND PULLED BACK REPETITIVELY. AS THE RESULT, THE RUNTHROUGH NS WAS SUBJECTED TO REPETITIVE BENDING FORCE AT THE BIFURCATION AND NITI CORE WIRE BECAME FRACTURED. THE FRACTURE CROSS-SECTION WAS NOTED TO BE ALMOST FLAT WITH THE GENERATION OF THE DIMPLE PATTERN ON THE 3/4 OF THE TOTAL AREA AND RADIAL PATTERN ON THE 1/4 OF THE TOTAL AREA. THERE WAS NO DEFORMATION INTO A FLEXED SHAPE OR DIMINISHMENT IN THE OUTSIDE DIAMETER TOWARD THE FRACTURE END. C. PULLING FORCE IN THE STATE OF THE SHAFT BEING FORMED INTO A LOOP SHAPE WITH THE SEGMENT AT APPROXIMATELY 35MM FROM THE DISTAL END OF THE DEVICE, THE RUNTHROUGH NS WAS PUSHED FORWARD WITH THE APPLICATION OF TORQUE FORCE AT THE SAME TIME. THE STAINLESS COIL SEGMENT BECAME BENT AND FORMED INTO A LOOP. SUBSEQUENTLY, WHEN PULLING FORCE WAS APPLIED, NITI CORE WIRE BECAME FRACTURED. THE CORE WIRE WAS NOTED TO HAVE BEEN FLEXED TOWARD THE FRACTURE END WITH THE FRACTURE CROSS-SECTION HAVING BEEN DISTORTED. THE STATE OF THE FRACTURE WAS FOUND TO DIFFER FROM THAT OF THE ACTUAL DEVICE. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. ALTHOUGH THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE INVESTIGATION, IT IS LIKELY THAT THE STAINLESS STEEL COIL SEGMENT OF THE ACTUAL SAMPLE INSERTED IN THE BIFURCATION AS A PROTECTION WIRE WAS SANDWICHED BETWEEN THE INVOLVED COMPETITOR'S STENT AND THE STENOSED LESION AND TRAPPED THERE. SUBSEQUENTLY, IN ATTEMPTS TO RELEASE THE TRAP, THE ACTUAL SAMPLE WAS SUBJECTED TO PUSHING AND PULLING MANIPULATIONS, WHEN EXCESSIVE REPETITIVE BENDING FORCE WAS GENERATED ON THE SHAFT AND NITI CORE WIRE LOCATED INSIDE THE STAINLESS STEEL COIL GOT FRACTURED AT APPROXIMATELY 40MM FROM THE DISTAL END OF THE DEVICE. DURING THE SUBSEQUENT WITHDRAWAL MANIPULATION, THE STAINLESS STEEL COIL BECAME UNRAVELED AND FINALLY FRACTURED. FROM THE AVAILABLE INFORMATION, HOWEVER, THE DEFINITIVE CAUSE CANNOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD AND THE SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER REPORT WITH THE INVOLVED PRODUCT CODE/LOT# COMBINATION. THE IFU STATES: "IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE RUNTHROUGH NS AND /OR THE DILATATION CATHETER AND DETERMINE THE CAUSE BY HIGH RESOLUTION FLUOROSCOPY. FAILURE TO EXERCISE PROPER CAUTION MAY RESULT IN BENDING, KINKING, SEPARATION OF THE GUIDE WIRE'S TIP, DAMAGE TO THE DILATATION CATHETER, OR DAMAGE TO THE VESSEL." TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834. EXEMPTION NUMBER E2015022.
THE USER FACILITY REPORTED THAT THE INVOLVED DEVICE FRACTURED. A PCI TO A CALCIFIED LESION IN THE RIGHT CORONARY ARTERY#2 WAS PERFORMED. A SION BLUE WAS INSERTED INTO THE MAIN TRUNK. THE ACTUAL SAMPLE AND A RUNTHROUGHNS FLOPPY WERE INSERTED INTO RV BRANCH AS THE PROTECTIVE WIRES. A SYNERGY 2.25 MM/ 32 MM AND A SYNERGY3.0 MM/ 38 MM WERE PLACED IN THE LESION IN THE MAIN TRUNK. WHEN THE ACTUAL SAMPLE WAS WITHDRAWN FOR THE FOLLOWING IMPLEMENTATION OF THE KISSING BALLOON TECHNIQUE, IT WAS TRAPPED WITH THE STENT AND WHEN FURTHER PULLED, IT BECAME FRACTURED. AN ATTEMPT TO REMOVE THE FRACTURED SEGMENTS WITH A SNARE WAS PERFORMED BUT FAILED. IT WAS REPORTED THAT THE PATIENT HAD SOME HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 71359 | RUNTHROUGH NS | GUIDEWIRE CATHETER | DQX | TERUMO CORPORATION, ASHITAKA | NA | 171108 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | RUNTHROUGH NS FLOPPY| SION BLUE| SYNERGY 2.25/32| SYNERGY 3.0/38| RUNTHROUGH NS FLOPPY| SION BLUE| SYNERGY 2.25/32| SYNERGY 3.0/38 |