RADIFOCUS GLIDEWIRE ADVANTAGE
Report
- Report Number
- 9681834-2022-00261
- Event Type
- Injury
- Date Received
- December 21, 2022
- Date of Event
- November 22, 2022
- Report Date
- December 21, 2022
- Manufacturer
- TERUMO CORPORATION, ASHITAKA
- Product Code
- DQX
- PMA / PMN Number
- K063372
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
UDI - N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PHONE NUMBER: UNKNOWN. HEALTH PROFESSIONAL: UNKNOWN. OCCUPATION: OTHERS. PMA/510(K) - K122590, K163004. THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. FOR THIS REASON, INVESTIGATION CONCLUSIONS CODE 11 HAS BEEN REFERENCED IN SECTION H6. REVIEW OF THE MANUFACTURING RECORD AND SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE FOUND NO ANOMALY IN THEM. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER SIMILAR REPORT WITH THE INVOLVED PRODUCT CODE/LOT# COMBINATION FROM OTHER FACILITIES. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).
THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP # 1 TO CORRECT SECTIONS D9 AND H3.
THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP NO. #2 TO UPDATE SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. INSPECTION OF THE ACTUAL SAMPLE AND THE BALLOON CATHETER. 1.1 VISUAL INSPECTION OF THE ACTUAL SAMPLE OBTAINED THE FOLLOWING RESULT. THE DISTAL END WAS DEFORMED. THE OUTER LAYER WAS BROKEN AND THE CORE WIRE WAS EXPOSED IN THE AREA 0- APPROXIMATELY 5 MM FROM THE DISTAL END. 1.2 MAGNIFYING INSPECTION OF THE ACTUAL SAMPLE OBTAINED THE FOLLOWING RESULT. THERE WAS A TRACE OF PROCESSING ON THE DISTAL END OF THE CORE WIRE. THE OUTER LAYER AND THE GOLD COIL WAS BROKEN. NO FLAW OR NO OTHER ANOMALIES WERE OBSERVED IN THE PROXIMAL SIDE OF THE DEFORMED DISTAL END. 1.3 ELECTRON MICROSCOPIC INSPECTION OF THE BROKEN SITE OF THE ACTUAL SAMPLE OBTAINED THE FOLLOWING RESULT. TRACE OF PROCESSING DURING MANUFACTURING WAS OBSERVED IN THE DISTAL END OF THE CORE WIRE (SIDE) AS SAME AS A NORMAL PRODUCT. TRACE OF PROCESSING DURING MANUFACTURING WAS OBSERVED IN THE DISTAL END OF CORE WIRE (TOP SURFACE) AS SAME AS A NORMAL PRODUCT. FROM THIS, IT WAS INFERRED THAT NO PORTION WAS MISSING FROM THE CORE WIRE. THE OUTER LAYER HAD BEEN TORN OFF AND CREASES WERE OBSERVED IN THE VICINITY. THE BROKEN END OF THE GOLD COIL WAS DIMINISHED IN DIAMETER. FROM THIS, IT WAS INFERRED THAT THE OUTER LAYER AND THE GOLD COIL WERE EXPOSED TO TENSILE FORCE. 1.4 ELECTRON MICROSCOPIC INSPECTION OF THE DEFORMED PART OF THE ACTUAL SAMPLE FOUND SCRATCHES ON THE OUTER SURFACE OF THE DEFORMED PART. FROM THIS, IT WAS INFERRED THAT EXTERNAL FORCE WAS APPLIED TO THE DISTAL END OF THE ACTUAL SAMPLE CAUSING IT DEFORMED. 1.5 VISUAL INSPECTION OF THE BALLOON CATHETER FOUND A FRAGMENT ATTACHED TO THE DISTAL END OF THE BALLOON CATHETER. 1.6 MAGNIFYING INSPECTION OF THE BALLOON CATHETER OBTAINED THE FOLLOWING RESULT. THE FRAGMENT HAD PENETRATED THE BALLOON CATHETER WALL. THE BALLOON CATHETER HAD A TEAR FROM ITS DISTAL END TO THE POINT PENETRATED BY THE FRAGMENT. 1.7 X-RAY FLUOROSCOPIC INSPECTION OF THE DISTAL END OF THE BALLOON CATHETER OBTAINED THE FOLLOWING RESULT. THE OUTER LAYER AND THE COIL INSIDE THE FRAGMENT WERE RADIOPAQUE. FROM THIS, IT WAS INFERRED THAT THE FRAGMENT WAS A PORTION OF THE OUTER LAYER AND THE GOLD COIL, WHICH HAD BEEN BROKEN AND SEPARATED FROM THE DISTAL PART OF THE ACTUAL SAMPLE. IN THE PART OF THE FRAGMENT LOCATED INSIDE THE BALLOON CATHETER, THE OUTER LAYER AND THE GOLD COIL WERE CONFIRMED TO HAVE BEEN BROKEN, AND THE COIL IN THE VICINITY OF THE BROKEN END HAD BEEN STRETCHED. 1.8 THE FRAGMENT WAS REMOVED FROM THE BALLOON CATHETER. MAGNIFYING INSPECTION OF THE FRAGMENT OBTAINED THE FOLLOWING RESULT. THE GOLD COIL HAD BEEN STRETCHED AND EXPOSED. THE OUTER LAYER HAD BEEN STRETCHED AND TORN OFF. LENGTH OF THE OUTER LAYER OF THE FRAGMENT: APPROX. 7 MM. 1.9 ELECTRON MICROSCOPIC INSPECTION OF THE FRAGMENT OBTAINED THE FOLLOWING RESULT. THERE WAS NO EXTERNAL DAMAGE ON THE OUTER LAYER SUCH AS SCRATCHES IN THE DISTAL END OF THE FRAGMENT. IN THE PROXIMAL (BROKEN) SIDE OF THE FRAGMENT, THE OUTER LAYER HAD BEEN STRETCHED, AND CREASES WERE OBSERVED NEAR THE EDGE. THE BROKEN END OF THE GOLD COIL WAS DIMINISHED IN DIAMETER. IT WAS CONFIRMED THAT THE CHARACTERISTICS OF THE BREAKAGE OF GOLD COIL WAS COMMON BETWEEN THE ACTUAL SAMPLE AND THE FRAGMENT, AND THE BROKEN EDGE OF THE OUTER LAYER OF THE ACTUAL SAMPLE MATCHED IN TERMS OF THE SHAPE WITH THAT OF THE FRAGMENT. IN ADDITION, THE LENGTH OF THE OUTER LAYER OF THE FRAGMENT WAS APPROXIMATELY 7 MM, WHICH WAS ROUGHLY MATCHED THE LENGTH OF THE EXPOSED CORE WIRE OF THE ACTUAL SAMPLE, WHICH WAS APPROXIMATELY 5 MM. FROM THIS, IT WAS INFERRED THAT THERE WAS NO PORTION MISSING FROM THE OUTER LAYER. (*NORMALLY, THE OUTER LAYER IS SLIGHTLY LONGER THAN THE CORE WIRE BECAUSE THE OUTER LAYER COVERS THE WIRE. IN ADDITION, THE BROKEN EDGE OF THE OUTER LAYER HAD BEEN STRETCHED.) 1.10 THE OUTER DIAMETER OF THE ACTUAL SAMPLE WAS MEASURED AT AN UNDAMAGED AREA AND CONFIRMED TO MEET THE FACTORY'S SPECIFICATIONS. BASED ON THE RESULTS OF THE INVESTIGATION, AS ONE OF POSSIBILITIES, IT WAS INFERRED THAT THE EVENT OCCURRED BY THE FOLLOWING MECHANISM. (1) THE DISTAL END OF THE ACTUAL SAMPLE WAS DEFORMED DUE TO AN APPLICATION OF SCRATCHING FORCE WHILE THE INVOLVED SECTION WAS IN CONTACT WITH SOME HARD OBJECT (SUCH AS A STENOTIC LESION). (2) THE ACTUAL SAMPLE IN THE STATE OF (1) WAS PULLED BACK INTO THE GUIDEWIRE LUMEN OF THE BALLOON CATHETER. (3) THE DEFORMED DISTAL END OF THE ACTUAL SAMPLE WAS STUCK IN THE DISTAL END OF THE BALLOON CATHETER. (4) THE ACTUAL SAMPLE IN THE STATE OF (3) WAS PULLED. AS A RESULT, THE GUIDEWIRE LUMEN OF THE BALLOON CATHETER WAS TORN, AND THE ACTUAL SAMPLE WAS STUCK IN THE MIDDLE. (5) WHEN THE ACTUAL SAMPLE WAS PULLED FURTHER, THE GOLD COIL AND THE OUTER LAYER WERE BROKEN OFF. (6) FINALLY, THE ACTUAL SAMPLE WAS REMOVED FROM THE BALLOON CATHETER, HOWEVER, THE FRAGMENT (OUTER LAYER OF THE DISTAL END) REMAINED IN THE TORN PART OF THE BALLOON CATHETER. IFU STATES: "IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GLIDEWIRE ADVANTAGE AND/OR THE CATHETER AND DETERMINE THE CAUSE BY FLUOROSCOPY. CONTINUING TO MANIPULATE OR ROTATE THE GLIDEWIRE ADVANTAGE OR FAILURE TO EXERCISE PROPER CAUTION MAY RESULT IN BENDING, KINKING, SEPARATION OF THE GUIDE WIRE'S TIP, DAMAGE TO THE 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.
THE USER FACILITY REPORTED THAT THE GUIDEWIRE, TIP BROKE OFF. ACCESS VIA RIGHT FEMORAL ARTERY AND ANTEGRADE PUNCTURE WITH MINI GUIDE WIRE, PROBING OF THE RIGHT FIBULAR ARTERY. INSERTION OF A PASSEO 18 2.5/200, THE WIRE WAS REMOVED, IT WAS NOTICED THAT THE TIP WAS TORN OFF. THE TIP COULD BE REMOVED WITH THE BALLOON CATHETER. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED. IT IS UNKNOWN IF THERE WERE ANY OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2023426 | RADIFOCUS GLIDEWIRE ADVANTAGE | WIRE, GUIDE, CATHETER | DQX | TERUMO CORPORATION, ASHITAKA | NA | 220317 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |