X-TREME XT-R
Report
- Report Number
- 3003775027-2023-00135
- Event Type
- Injury
- Date Received
- December 27, 2023
- Date of Event
- December 11, 2023
- Report Date
- July 19, 2024
- Manufacturer
- ASAHI INTECC CO., LTD.
- Product Code
- DQX
- UDI-DI
- 04547327123433
- PMA / PMN Number
- K171933
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
UDI RELATED DATA QUALITY UPDATES ONLY AS WE RECEIVED AN EMAIL TIME-STAMPED SATURDAY, JULY 6, 2024 1:27 AM AT OUR END FROM (B)(4), MDR DATA SYSTEMS TEAM, TO INFORM US OF THE DISCREPANCIES IN THE DEVICE IDENTIFICATION FIELDS OF OUR SUBMITTED ELECTRONIC EQUIVALENT OF THE FDA FORM 3500A WHEN COMPARED WITH THE INFORMATION IN THE GUDID. THE SUBJECT DEVICE WAS INITIALLY REPORTED AS X-TREME XT-R WHICH IS DISTRIBUTED AS FIELDER XT-R IN THE US; THEREFORE, BRAND NAME IN BLOCK D1 WAS CHANGED FROM FIELDER XT-R TO X-TREME XT-R AS INDICATED IN THE PACKAGE LABEL OF THE SUBJECT DEVICE. ALTHOUGH FIELDER XT-R IS CURRENTLY US MARKETED, THE SUBJECT MODEL IS SOLD OUTSIDE THE US UNDER THE BRAND NAME X-TREME XT-R. AFTER COMPARING THE INFORMATION IN THE PREVIOUS SUBMITTED MDR WITH THAT OF FIELDER XT-R IN THE CORRESPONDING FIELDS IN THE GUDID, WE DETERMINED TO SUBMIT THIS SUPPLEMENTAL REPORT. THE CHANGES WE INTEND TO MAKE ARE AS FOLLOWS: D3: MANUFACTURER NAME, CITY, AND STATE - FROM ASAHI INTECC CO., LTD. TO ASAHI INTECC CO., LTD. D4: MODEL # - FROM NO ENTRY TO R0419-Z6PSR CATALOG # - FROM R0419-Z6PSR TO NO ENTRY G1: CONTACT OFFICE - FROM ASAHI INTECC CO., LTD. TO ASAHI INTECC CO., LTD. H4: DEVICE MANUFACTURE DATE - FROM 01-8-2023 TO NO ENTRY.
MANUFACTURING SITE: ASAHI INTECC HANOI CO., LTD. HANOI, VIETNAM, REGISTRATION NUMBER: 3009121749. THE REPORTED FIELDER XT-R GUIDE WIRE WAS RETURNED FOR EVALUATION. ORIGINATING FROM THE PROXIMAL SOLDER (SET AT 160MM FROM THE TIP FOR THE PURPOSE OF FIXING THE OUTER COIL ONTO THE CORE), THE OUTER COIL AND THE POLYMER JACKET WERE FOUND STRETCHED. THE OUTER COIL WAS FOUND FRACTURED AT APPROXIMATELY 140MM DISTAL TO THE PROXIMAL SOLDER. AT ALMOST THE SAME SITE, THE CORE THAT WAS DEFORMED IN A HOOK-LIKE SHAPE WAS FOUND FRACTURED. THE STRETCHED POLYMER JACKET WAS FOUND INTERMITTENTLY TORN APART ON THE STRETCHED OUTER COIL. MICROSCOPIC OBSERVATION FOUND THAT THE CORE FRACTURE END WAS TWISTED AND HAD A FLAT FRACTURE SURFACE, INFERRING THAT ACCUMULATED TORSION HAD CONTRIBUTED TO THE CORE FRACTURE. PROXIMAL TO THE CORE FRACTURE END, TRACES OF SOLDER WERE OBSERVED. THE FRACTURE END OF THE OUTER COIL WAS FOUND TWISTED AND NECKED BY TORSION AND TENSILE TRESS THAT WERE LIKELY GENERATED WHEN THE OUTER COIL WAS PULLED AND STRAIGHTENED. MEASUREMENT OF THE RETURNED GUIDE WIRE SUGGESTED THAT APPROXIMATELY 20MM OF THE CORE AND APPROXIMATELY 130MM OF THE OUTER COIL WITH THE INNER COIL AND THE BALL TIP WERE MISSING. LOT HISTORY REVIEW REVEALED NO ANOMALY RELATING TO THE REPORTED EVENT. NO OTHER SIMILAR PRODUCT EXPERIENCE REPORT WAS RECEIVED FROM THIS LOT. BASED ON THE OBTAINED INFORMATION AND THE INVESTIGATION OUTCOME, IT WAS PRESUMED THAT TORSION GENERATED WITH TORQUING MANIPULATION MIGHT HAVE BEEN LOCALLY ACCUMULATED ON THE FIELDER XT-R GUIDE WIRE WHILE THE WIRE TIP WAS CAUGHT BETWEEN THE STENTS OR BETWEEN THE STENT AND THE VESSEL WALL, FRACTURING THE CORE. FURTHER APPLIED TENSILE STRESS THEN MADE THE OUTER COIL STRETCH TO FRACTURE. CONSEQUENTLY, THE WIRE TIP WAS SEPARATED. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. NO CAPA WILL BE TAKEN. INSTRUCTIONS FOR USE (IFU) STATES: [WARNINGS] OBSERVE MOVEMENT OF THIS GUIDE WIRE IN THE VESSELS. BEFORE THIS GUIDE WIRE IS MOVED OR TORQUED, THE TIP MOVEMENT SHOULD BE EXAMINED AND MONITORED UNDER FLUOROSCOPY. DO NOT MOVE OR TORQUE THE GUIDE WIRE WITHOUT OBSERVING CORRESPONDING MOVEMENT OF THE TIP; OTHERWISE, THE GUIDE WIRE MAY BE DAMAGED AND/OR TRAUMA MAY OCCUR. IN ADDITION, ENSURE THAT THE DISTAL TIP OF THIS GUIDE WIRE AND ITS LOCATION IN THE VESSEL ARE VISIBLE DURING MANIPULATIONS OF THE GUIDE WIRE. NEVER PUSH, AUGER, WITHDRAW, OR TORQUE THIS GUIDE WIRE THAT MEETS RESISTANCE. TORQUING OR PUSHING THIS GUIDE WIRE AGAINST RESISTANCE MAY CAUSE DAMAGE AND/OR TIP SEPARATION OF THIS GUIDE WIRE OR DIRECT DAMAGE TO A VESSEL. RESISTANCE MAY BE FELT AND/OR OBSERVED UNDER FLUOROSCOPY BY NOTING ANY BUCKLING OF THE GUIDE WIRE. IF THE PROLAPSE OF THE GUIDE WIRE TIP IS OBSERVED, DO NOT ALLOW THE TIP TO REMAIN IN A PROLAPSED POSITION; OTHERWISE DAMAGE TO THE GUIDE WIRE MAY OCCUR. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE ANY NECESSARY REMEDIAL ACTION. IF RESISTANCE IS FELT DUE TO SPASM, BENDING OF THE GUIDE WIRE, OR DUE TO TRAP WHILE OPERATING THIS GUIDE WIRE IN THE BLOOD VESSEL OR REMOVING IT, DO NOT TORQUE AND/OR PULL THE GUIDE WIRE ITSELF. STOP THE PROCEDURE. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE APPROPRIATE REMEDIAL ACTION. IF THE GUIDE WIRE IS MOVED EXCESSIVELY, IT MAY BREAK OR BECOME DAMAGED, WHICH MAY CAUSE BLOOD VESSEL INJURY OR RESULT IN FRAGMENTS BEING LEFT INSIDE THE VESSEL. WHEN TORQUING THIS GUIDE WIRE INSIDE THE BLOOD VESSEL, DO NOT TORQUE CONTINUOUSLY IN THE SAME DIRECTION. THIS MAY CAUSE THE GUIDE WIRE TO BECOME DAMAGED OR BREAK APART, CAUSING INJURY TO THE BLOOD VESSEL OR LEAVING FRAGMENTS INSIDE THE VESSEL. WHEN TORQUING THE GUIDE WIRE, ROTATE IT CLOCKWISE AND COUNTERCLOCKWISE ALTERNATELY. DO NOT EXCEED TWO ROTATIONS (720 DEGREES) IN THE SAME DIRECTION. DO NOT PERFORM STENT PLACEMENT USING MORE THAN ONE GUIDE WIRE OR WIRE OPERATION THROUGH STENT STRUT. OTHERWISE, THE STENT MAY BE DAMAGED OR THE GUIDE WIRE MAY BREAK OR BREAK APART. [MALFUNCTION AND ADVERSE EFFECTS] SEPARATION OF THE GUIDE WIRE.
IT WAS REPORTED THAT AN ASAHI FIELDER XT-R GUIDE WIRE HAD FRACTURED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A HEAVILY CALCIFIED 75-90% STENOSIS IN SEGMENTS #2-3 OF THE RIGHT CORONARY ARTERY (RCA). AFTER THE FIELDER XT-R GUIDE WIRE WAS ADVANCED TO THE PERIPHERAL OF SEGMENT #3 WITH THE SUPPORT OF A NON-ASAHI MICROCATHETER, AN ASAHI SION BLUE GUIDE WIRE WAS ALSO ADVANCED TO THE PERIPHERAL OF SEGMENT #3. WHEN A NON-ASAHI SCOREFLEX SCORING BALLOON CATHETER WAS ADVANCED, THE BALLOON CATHETER COULD NOT BE DELIVERED DUE TO SEVERE CALCIFICATION. THE SION BLUE GUIDE WIRE WAS THEN EXCHANGED FOR AN ASAHI SION BLUE ES GUIDE WIRE. A NON-ASAHI GUIDEPLUS ST GUIDE EXTENSION CATHETER WAS DELIVERED TO SEGMENT #2 USING ANCHOR BALLOON TECHNIQUE. AFTER PRE-DILATATION WITH BALLOON AND DEPLOYMENT OF A NON-ASAHI COROFLEX ISAR NEO STENT IN SEGMENTS #2-3, THE FIELDER XT-R GUIDE WIRE WAS FOUND MOVED BACKWARD. THE FIELDER XT-R GUIDE WIRE WAS THEN ADVANCED THROUGH THE STENT AGAIN WITH THE SUPPORT OF AN ASAHI SASUKE MICROCATHETER. AFTER PRE-DILATATION OF SEGMENT #1 AND DEPLOYMENT OF A NON-ASAHI SYNERGY STENT, THE FIELDER XT-R GUIDE WIRE WAS FOUND CAUGHT BY THE STENT AND FRACTURED. AS ATTEMPTS TO RETRIEVE THE SEPARATED WIRE FRAGMENT WERE UNSUCCESSFUL, A STENT WAS DEPLOYED TO EMBED THE FRAGMENT. ALTHOUGH THE BLOOD FLOW WAS NOT RECOVERED, GIVEN THE COLLATERAL CHANNELS FROM THE LEFT CORONARY ARTERY AND NO FINDINGS OF ST ELEVATION, THE PROCEDURE WAS TERMINATED. IT WAS INFORMED THAT THE PATIENT HAD NO COMPLICATIONS AFTER THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2297567 | X-TREME XT-R | PTCA GUIDE WIRE | DQX | ASAHI INTECC CO., LTD. | R0419-Z6PSR | 230717A11A | 04547327123433 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Male | Disability| R |