VASSALLO GT
Report
- Report Number
- 3012223769-2024-00009
- Event Type
- Injury
- Date Received
- November 7, 2024
- Date of Event
- October 9, 2024
- Report Date
- November 7, 2024
- Manufacturer
- FILMECC CO., LTD.
- Product Code
- DQX
- UDI-DI
- 04562102681014
- PMA / PMN Number
- K203533
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
*ALTHOUGH THE PRODUCT IS NOT DISTRIBUTED IN THE U.S., BUT IN JAPAN, SIMILAR PRODUCTS (PRODUCT FAMILY) ARE DISTRIBUTED IN THE U.S. THEREFORE, MDR IS BEING IMPLEMENTED. MANUFACTURING SITE: ASAHI INTECC (THAILAND) CO., LTD., PATHUM THANI, THAILAND, REGISTRATION NUMBER: (B)(4). [MANUFACTURING RECORDS] ALL PRODUCTS WERE CONFIRMED TO HAVE PASSED INSPECTION. [LOT HISTORY REVIEW] NO OTHER SIMILAR PRODUCT EXPERIENCE REPORT WAS RECEIVED FROM THIS LOT. [COMPLAINT HISTORY REVIEW] COMPLAINTS ABOUT PRODUCTS OF THE SAME STRUCTURE (VGW1423FL0, VGW1430FL0) OVER THE PAST THREE YEARS SHOWED THAT THE NUMBER OF EVENTS OF SEPARATION WAS SMALL AND DID NOT SHOW AN INCREASING TREND. [RETURNED PRODUCT INVESTIGATION] THE PRODUCT WAS RETURNED FOR INVESTIGATION. AT THE TIP OF THE PRODUCT, THE COIL WAS SEVERELY TWISTED AND THREE-DIMENSIONALLY DEFORMED, AND THE COIL AND CORE WIRE WERE BROKEN AT A POSITION APPROXIMATELY 25 MM FROM THE TIP. A KINK WITH INDENTATION AND DAMAGE TO THE POLYMER JACKET WERE OBSERVED AT APPROXIMATELY 2 MM FROM THE TIP OF THE DETACHED PIECE. A KINK OCCURRED AT APPROXIMATELY 160 MM FROM THE TIP. AFTER REMOVING THE POLYMER JACKET FROM THE DETACHED PIECE OF THE TIP SIDE AND DETACHED POSITION OF PORXIMAL SIDE, AND CONFIRMED THE CORE WIRE AND COIL, THE COIL PITCH WAS FOUND TO BE OPEN AT A DEFORMATION POSITION OF APPROXIMATELY 2 MM FROM THE TIP. AT THE TIP SIDE, THE CORE WIRE WAS BROKEN AT ABOUT 22 MM FROM THE TIP. AT THE DETACHED POSITION OF THE PROXIMAL SIDE, THE CORE WIRE AND COIL WERE TORN AT A DISTANCE OF APPROXIMATELY 2 MM FROM THE DETACHED POSITION OF THE POLYMER JACKET TO THE PROXIMAL END. MAGNIFIED OBSERVATION OF THE CORE WIRE AND COIL TEAR SURFACE BY SCANNING ELECTRON MICROSCOPE, RESPECTIVELY, CONFIRMED THAT DIMPLES WERE GENERATED ON THE TEAR SURFACE OF THE CORE WIRE DUE TO STRETCHING LOAD, AND THAT TWISTING WAS GENERATED ON THE TEAR SURFACE OF THE COIL DUE TO ROTATION AND PUSH-PULL OPERATIONS. BASED ON THE INFORMATION OBTAINED AND THE RESULTS OF THE ABOVE INVESTIGATION, IT IS CONSIDERED THAT WHEN THE PRODUCT WAS PASSED THROUGH A LESION WITH 100% OCCLUSION RATE WITH HIGH CALCIFICATION, THE TIP OF THE PRODUCT WAS REPEATEDLY ROTATED AND PUSHED AND PULLED WHILE TRAPPED IN THE CALCIFICATION, CAUSING TERTIARY DEFORMATION AND DAMAGE TO THE CORE WIRE WITH DAMAGE TO THE POLYMER JACKET, THE RESISTANCE BETWEEN THE MICROCATHETER USED IN COMBINATION WITH THE PRODUCT CAUSED A TENSILE LOAD TO THE CORE WIRE DURING OPERATION, WHICH WAS CONSIDERED TO HAVE LED TO THE BREAKAGE OF THE CORE WIRE.THE COIL ALSO SHOWED EVIDENCE OF A STRONG TWISTING LOAD, SUGGESTING THAT THE WIRE WAS LOCALLY TWISTED AT THE SOLDERING AREA AND, AS WITH THE CORE WIRE, BROKE WHEN A TENSILE LOAD WAS APPLIED. BASED ON THE ABOVE, IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTABLE TO THE PRODUCT QUALITY BUT TO THE PROCEDURE. HOWEVER, AN ADDITIONAL PROCEDURE WAS REQUIRED FOR THE REMOVAL OF THE DETACHED PIECE AND IT CANNOT BE COMPLETELY RULED OUT THAT THE POSSIBILITY OF THE DETACHED FRAGMENTS REMAINING IN THE PATIENT'S BODY. INSTRUCTIONS FOR USE (IFU) STATES BELOW AND NO CAPA WILL BE TAKEN. [WARNINGS] ~NEVER PUSH, AUGER, WITHDRAW, OR TORQUE A GUIDE WIRE THAT MEETS RESISTANCE. TORQUING OR PUSHING A GUIDE WIRE AGAINST RESISTANCE MAY CAUSE GUIDE WIRE DAMAGE AND/OR GUIDE WIRE TIP SEPARATION OR DIRECT DAMAGE TO A VESSEL. RESISTANCE MAY BE FELT AND/OR OBSERVED UNDER FLUOROSCOPY BY NOTING ANY BUCKLING OF THE GUIDE WIRE TIP. IF GUIDE WIRE TIP PROLAPSE 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. ~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 PUSH THE GUIDE WIRE MORE THAN NECESSARY TO ADVANCE THE TIP THROUGH THE NARROWED PART OF THE VESSEL. (FOR EXAMPLE, DO NOT PUSH THE GUIDE WIRE WHEN THE DISTAL TIP OF THE GUIDE WIRE IS BENT BY THE FORCE OF MANIPULATION.) AFTER CROSSING THE TARGETED AREA, DO NOT ROUGHLY TWIST, PUSH OR PULL THE GUIDE WIRE. IF THE GUIDE WIRE IS MOVED EXCESSIVELY, IT MAY BE DAMAGED OR BREAK APART, WHICH MAY INJURE THE BLOOD VESSEL OR LEAVE FRAGMENTS INSIDE THE VESSEL. [MALFUNCTION AND ADVERSE EFFECTS] POSSIBLE COMPLICATIONS AND ADVERSE EVENTS OF GUIDE WIRE USE INCLUDE, BUT ARE NOT LIMITED TO: DAMAGE OF GUIDEWIRE (SEPARATION, BREAKAGE).
IT WAS REPORTED THAT VASSALLO GT .014 FLOPPY (THE PRODUCT) WAS USED IN A CASE OF A BELOW-KNEE LESION WITH 100% OCCLUSION RATE AND HIGH CALCIFICATION. THE PRODUCT WAS USED AS A DISTAL PUNCTURE WIRE, BUT IT WAS TRAPPED IN CALCIFICATION AND BROKE, PROBABLY DUE TO TENSION AT THE TIP OF THE MICROCATHETER (MANUFACTURED BY ASAHI INTECC: CORSAIR ARMET). THE COIL DID NOT UNRAVEL, AND THE CORE WIRE APPEARS TO HAVE BEEN TORN. THE TORN PIECE WAS REMOVED FROM THE PATIENT'S BODY WITH A SNARE, SO THERE IS NO HEALTH HAZARD ON THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1860981 | VASSALLO GT | PERIPHERAL GUIDE WIRE | DQX | FILMECC CO., LTD. | VGW1430FL0 | 240515R021 | 04562102681014 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |