VASSALLO GT
Report
- Report Number
- 3012223769-2024-00005
- Event Type
- Injury
- Date Received
- October 3, 2024
- Date of Event
- September 3, 2024
- Report Date
- October 3, 2024
- Manufacturer
- FILMECC CO., LTD.
- Product Code
- DQX
- UDI-DI
- 04562102681045
- PMA / PMN Number
- K203533
- Adverse Event
- Yes
- Product Problem
- 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, PMA/510(K): K203533) ARE DISTRIBUTED IN THE U.S. THEREFORE, THE MDR IS BEING IMPLEMENTED. SINCEFILMECC BECAME AWARE OF THE REPORTABLE MALFUNCTION AND ADVERSE EVENT UPON RECEIPT OF THE PRODUCT, THE DATE OF FILMECC RECEIPT OF THE PRODUCT WAS ENTERED IN G3 DATE RECEIVED BY MANUFACTURER. MANUFACTURING SITE: ASAHI INTECC (THAILAND) CO., LTD., PATHUM THANI, THAILAND, REGISTRATION NUMBER: 3003780911. [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 (VGW1419G40, VGW1419G14) OVER THE PAST THREE YEARS SHOWED THAT THE NUMBER OF EVENTS OF BROKEN OFF AND PEELING WAS SMALL AND DID NOT SHOW AN INCREASING TREND. [RETURNED PRODUCT INVESTIGATION] THE PRODUCT WAS RETURNED FOR EVALUATION. IT WAS CONFIRMED THAT THE COIL HAD UNRAVELED AND BROKEN OFF AT A LOCATION APPROXIMATELY 15 MM FROM THE TIP OF THE PRODUCT. IN ADDITION, IT WAS CONFIRMED THAT CURVED DEFORMATION HAD OCCURRED AT SEVERAL LOCATIONS ON THE SHAFT AND THAT THE PTFE COATING HAD PEELED OFF AT SEVERAL LOCATIONS IN THE RANGE OF APPROXIMATELY 880 MM TO 950 MM FROM THE PROXIMAL END. AS A RESULT OF OBSERVATION OF THE BROKEN PART OF THE COIL USING A SCANNING ELECTRON MICROSCOPE, IT WAS CONFIRMED THAT DIMPLES WERE GENERATED IN THE CROSS SECTION AT THE TIP OF THE BROKEN PART DUE TO THE STRETCHING LOAD. BASED ON THE INFORMATION OBTAINED AND THE CONDITION OF THE RETURNED PRODUCT, IT WAS PRESUMED THAT THE COIL NEAR THE MIDDLE SOLDERING AREA MAY HAVE BEEN BROKEN DUE TO REPEATED ROTATION IN THE SAME DIRECTION WHILE THE TIP OF THE PRODUCT WAS STUCK IN THE CALCIFIED STENOSIS AREA BY BEING TRAPPED IN THE CALCIFIED AREA DURING THE PROCESS OF APPROACHING THE CALCIFIED STENOSIS AREA, AND THAT EXCESSIVE TENSILE LOAD DURING REMOVAL OF THE PRODUCT MAY HAVE CAUSED THE COIL TO BREAK OFF. THE CURVED DEFORMATION OF THE SHAFT AT SEVERAL LOCATIONS WAS CONSIDERED TO HAVE BEEN CAUSED BY PUSHING AND PULLING WHEN THE PRODUCT WAS USED, AND THE PEELING OF THE PTFE COATING AT SEVERAL LOCATIONS WAS CONSIDERED TO HAVE BEEN CAUSED BY EXCESSIVE CONTACT WITH THE TORQUER, BASED ON THE PEELING CONDITION OF THE PRODUCT. BASED ON THE ABOVE, IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTABLE TO THE PRODUCT QUALITY BUT TO THE PROCEDURE, HOWEVER, IT CANNOT BE SAID THAT THERE IS NO POSSIBILITY OF SERIOUS HEALTH HAZARD IN THE EVENT OF RECURRENCE OF THE SIMILAR EVENT, AND THE POSSIBILITY OF THE DETACHED FRAGMENTS REMAINING IN THE PATIENT'S BODY CANNOT BE COMPLETELY RULED OUT. 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?) 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, DAMAGE OF COATING).
IT WAS REPORTED THAT VASSALLO GT .014 G40 (THE PRODUCT) WAS USED IN A CASE OF A LESION IN THE RIGHT SFA TO BELOW-KNEE OCCLUSION WITH HIGH CALCIFICATION AND ITS OCCLUSION RATE WAS LESS THAN 100% TO 70%. AN IPSILATERAL APPROACH WAS MADE THROUGH THE RIGHT INGUINAL REGION TO THE CALCIFIED STENOSIS. DURING USE, WHEN THE TIP OF THE PRODUCT WAS REMOVED FROM THE PATIENT'S BODY FOR RESHAPING, A BUMP WAS FOUND AT ABOUT 2 MM FROM THE TIP AND IT WAS DISCONTINUED TO USE. THE PROCEDURE WAS COMPLETED WITHOUT PROBLEMS USING VARIOUS COMBINATIONS OF OTHER COMPANIES' PRODUCTS (DETAILS UNKNOWN) AND PASSED THROUGH THE OCCLUDED AREA AND DILATED THE LESION. THERE WAS NO HEALTH HAZARD ON THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1290654 | VASSALLO GT | PERIPHERAL GUIDE WIRE | DQX | FILMECC CO., LTD. | VGW1419G40 | 230327R031 | 04562102681045 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |