RADIFOCUS GUIDEWIRE ADVANTAGE
Report
- Report Number
- 9681834-2024-00121
- Event Type
- Injury
- Date Received
- July 12, 2024
- Date of Event
- May 27, 2024
- Report Date
- July 12, 2024
- Manufacturer
- TERUMO CORPORATION, ASHITAKA
- Product Code
- DQX
- PMA / PMN Number
- K063372
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED A2: AGE & DATE OF BIRTH: REQUESTED, NOT PROVIDED A3A: SEX: REQUESTED, NOT PROVIDED A3B: GENDER: REQUESTED, NOT PROVIDED A4: WEIGHT: REQUESTED, NOT PROVIDED A5: ETHNICITY: REQUESTED, NOT PROVIDED A6: RACE: REQUESTED, NOT PROVIDED D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED E1: PHONE NUMBER: UNKNOWN G4: 510(K) NUMBER: K122590, K163004 THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. NO OTHER SIMILAR REPORT WAS FOUND IN THE PAST COMPLAINT FILE. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO.(B)(4).
THIS REPORT IS BEING SENT AS FOLLOW-UP NO. 1 TO UPDATE SECTION D9, SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. 1. INVESTIGATION OF THE ACTUAL SAMPLE: 1.1 VISUAL AND MAGNIFYING INSPECTIONS · THE GOLD COIL HAD BEEN EXPOSED AND ELONGATED AT THE DISTAL END. · THE OUTER LAYER HAD BEEN FRACTURED AND ELONGATED AT THE DISTAL END. · THE WIRE WAS NOT EXPOSED AT THE DISTAL END. · NO ANOMALY WAS FOUND IN OTHER SECTIONS. 1.2 ELECTRON MICROSCOPIC INSPECTION OF THE WIRE THE WIRE WAS EXPOSED AND ELECTRON MICROSCOPIC INSPECTION OF IT WAS PERFORMED. · DIMPLE PATTERNS WERE FOUND ON THE FRACTURED SURFACE. · THERE WAS NO FIXED SIZE CUT MARK (THE MARK CREATED WHEN CUTTING THE WIRE DURING MANUFACTURING) THAT WAS FOUND ON THE REGULAR PRODUCT. · NO TAPER WAS FOUND AT THE SIDE ON THE FRACTURED SECTION. - SINCE NO FIXED SIZE CUT MARK WAS FOUND, IT WAS INFERRED THAT THE WIRE WAS ALSO FRACTURED. 1.3 CONFIRMATION OF THE MISSING LENGTH · FROM THE DISTAL END OF WIRE TO THE END OF HYDROPHILIC COATING SECTION: APPROXIMATELY 246MM - SINCE THE EFFECTIVE LENGTH OF HYDROPHILIC COATING SECTION IS 250MM, IT WAS INFERRED TO BE MISSING APPROX. 4MM. 1.4 MEASUREMENT OF DIMENSION · OUTER DIAMETERS OF THE HYDROPHILIC COATING SECTION AND THE PTFE COATING SECTION MET THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND. 2. SIMULATION TEST: WE HAVE BEEN AWARE THAT THE GUIDEWIRE WAS FRACTURED WHEN THE FOLLOWING FORCE A) - D) WAS APPLIED. WE HAVE ALSO BEEN AWARE THAT THERE WERE CHARACTERISTICS IN THE SHAPE AT THE SIDE ON THE FRACTURED SECTION AND AT THE FRACTURED SURFACE ON THE WIRE DEPENDING ON THE MECHANISM LEADING TO THE FRACTURE. A. WHEN PULLING FORCE WAS APPLIED · THE SIDE ON THE FRACTURED SECTION OF WIRE WAS TAPERED, AND DIMPLE PATTERNS (HOLE-SHAPED PATTERNS) WERE FOUND ON THE FRACTURED SURFACE. B. WHEN REPEATED BENDING FORCE (REPEATED 90° BENDING FORCE) WAS APPLIED · NO TAPER WAS FOUND AT THE SIDE ON THE FRACTURED SECTION OF WIRE, AND DIMPLE PATTERNS (HOLE-SHAPED PATTERNS) WERE FOUND ON THE FRACTURED SURFACE. - THIS CONDITION WAS SIMILAR TO THAT OF THE ACTUAL SAMPLE. C. WHEN CONTINUOUS TORQUE FORCE WAS APPLIED IN THE SAME DIRECTION [IN THE BENT STATE] · NO TAPER WAS FOUND AT THE SIDE ON THE FRACTURED SECTION OF WIRE, AND RADIAL PATTERNS WERE FOUND ON THE FRACTURED SURFACE. [IN THE STRAIGHT STATE] · NO TAPER WAS FOUND AT THE SIDE ON THE FRACTURED SECTION OF WIRE, AND SPIRAL PATTERNS STARTING FROM THE CENTER WERE FOUND ON THE FRACTURED SURFACE. D. WHEN PULLING FORCE WAS APPLIED IN A LOOPED STATE · THE SIDE ON THE FRACTURED SECTION OF WIRE WAS CURVED AND TAPERED, AND THE FRACTURED SURFACE WAS ROUGHENED. 3. CAUSE OF OCCURRENCE/CONCLUSION: BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING HISTORY RECORDS AND DIMENSIONS OF THE ACTUAL SAMPLE. FROM THE REPORTED ISSUE, CONDITION OF THE ACTUAL SAMPLE, AND THE SIMULATION TEST RESULT, FOLLOWING FACTOR WAS INFERRED AS A POSSIBLE CAUSE OF THIS CASE. · THE GUIDEWIRE GOT STUCK FOR SOME FACTORS. · SINCE REPEATED BENDING FORCE WAS APPLIED TO RELEASE THE STUCK PART, THE WIRE WAS FRACTURED. · THEN, PULLING FORCE WAS APPLIED TO THE GUIDEWIRE IN THE REMOVAL DIRECTION, CAUSING THE COIL AND THE OUTER LAYER TO ELONGATE AND FRACTURE. RELEVANT IFU REFERENCE: "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. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).
THE USER FACILITY REPORTED THAT THE TIP OF THE INVOLVED GUIDEWIRE BROKE OFF. AT THE ANGIO-SUITE THE DOCTOR HAD A PATIENT WITH A THORACIC OUTLET SYNDROME (TOS). THE PATIENT HAD IN THE PAST ALREADY UNDERWENT SURGERY (TOD). THE PATIENT CAME TO THE ANGIO-SUITE FOR A RECANALIZATION OF THE LEFT V. SUBCLAVIA. ACCESS WAS GAINED ON THE ARM, V. BRACHIALIS, WITH A 5 FRENCH SHEATH. THE DOCTOR STARTED WORKING WITH A MACRO CATHETER (BERENSTEIN) AND A DIFFERENT VARIETY OF WIRES IN COMBINATION WITH A 0.014" CXI SUPPORT CATHETER. IT WAS A DIFFICULT RECANALIZATION. FROM THE ARM, THE DOCTOR USED OUR GWA TRACK, 0,014" WITH A LENGTH OF 180 CM. ALSO, ACCESS WAS GAINED FROM THE GROIN SO THEY COULD WORK FROM BOTH SIDES. DURING THE RECANALIZATION A PART OF THE TIP OF OUR GWA TRACK CAME SEPARATED FROM THE WIRE AND GOT STUCK IN THE VENOUS VESSEL WALL. AFTER, THE DOCTOR CHECKED IF THE BROKEN TIP WAS STABLE, AND IT WAS. THEREFORE, THE DOCTOR TOOK A NEW WIRE AND THE GWA TRACK 0.014" AND CONTINUED THE PROCEDURE. THE PROCEDURE WAS NOT SUCCESSFUL IN THE END; HOWEVER, THIS HAD NOTHING TO DO WITH THE SEPARATION OF THE TIP OF ONE OF OUR WIRES. IN THIS CASE, IT WAS A VERY DIFFICULT RECANALIZATION WITH A LOT OF SCAR TISSUE. THIS HAD NO NEGATIVE EFFECTS ON THE PATIENT OR THE OUTCOME OF THE PROCEDURE. IT WAS A VERY DIFFICULT PROCEDURE WHERE SEVERAL TECHNIQUES WERE USED TO CROSS THIS LESION. NONE OF THEM WERE SUCCESSFUL. THE GUIDEWIRE BROKE OFF AND REMAINED IN THE PATIENT. THE PROCEDURE OUTCOME WAS NOT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 236469 | RADIFOCUS GUIDEWIRE ADVANTAGE | WIRE, GUIDE, CATHETER | DQX | TERUMO CORPORATION, ASHITAKA | N/A | 231011 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other | 0.014" CXI SUPPORT CATHETER.| MACRO CATHETER (BERENSTEIN). |