RADIFOCUS GUIDEWIRE M
Report
- Report Number
- 9681834-2025-00258
- Event Type
- Injury
- Date Received
- January 23, 2026
- Date of Event
- December 25, 2025
- Report Date
- January 23, 2026
- Manufacturer
- TERUMO CORPORATION, ASHITAKA
- Product Code
- DQX
- PMA / PMN Number
- K863138
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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. A4: WEIGHT: REQUESTED, NOT PROVIDED. A5: ETHNICITY: REQUESTED, NOT PROVIDED. A6: RACE: REQUESTED, NOT PROVIDED. D4: LOT NUMBER: REQUESTED, UNKNOWN. D4: EXPIRATION DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER. D4: UDI NO. N/A AS THIS PRODUCT IS NOT EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. G4: 510(K) NUMBER: K923607, K926214. H4: DEVICE MANUFACTURE DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER. 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. HISTORY INVESTIGATION OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER - SINCE THE LOT NUMBER WAS UNKNOWN, THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD COULD NOT BE INVESTIGATED. - COMPLAINT FILES FROM THE PAST TWO YEARS WERE INVESTIGATED. NO DEVIATIONS OR NON-CONFORMITIES RELATED TO THE MANUFACTURING PROCESS FOR THE INVOLVED CASE WAS FOUND. TERUMO MEDICAL CORPORATION (TMC) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.
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. THE RETURNED DEVICE: - A FRACTURED PIECE. - THE LENGTH OF THE FRACTURED PIECE: APPROXIMATELY 236MM. - SINCE IT IS NOTED THAT THE DISTAL END WAS APPROXIMATELY 20CM SEPARATED, THIS IS NOT DISCREPANT TO THE COMPLAINT. APPEARANCE CONFIRMATION: - THE TWIST OF THE OUTER LAYER AND THE SHAPE THAT SEEMED TO BE TORN OFF WERE OBSERVED AT THE FRACTURED PART. - NO EXPOSURE OF WIRE STRAND WAS OBSERVED AT THE FRACTURED PART. - NO ANOMALIES SUCH AS ABRASION OR DEFORMATION IN APPEARANCE IN OTHER PARTS. APPEARANCE CONFIRMATION OF THE WIRE STRAND: THE OUTER LAYER OF THE FRACTURED PIECE WAS REMOVED TO CONFIRM THE CONDITION OF THE WIRE STRAND AT THE FRACTURED PART. - NO TAPERING IS OBSERVED ON THE SIDE OF THE WIRE STRAND AT THE FRACTURED PART. - RADIAL PATTERNS WERE OBSERVED ON THE TOP SURFACE OF THE WIRE STRAND AT THE FRACTURED PART. DIMENSION: - THE OUTER DIAMETER (NORMAL PART): IT MET THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND. HISTORY INVESTIGATION OF THE INVOLVED PRODUCT CODE AND LOT NUMBER: - SINCE THE LOT NUMBER WAS UNKNOWN, THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD COULD NOT BE INVESTIGATED. - REGARDING THE INVOLVED PRODUCT, NO SIMILAR REPORTS ATTRIBUTABLE TO THE MANUFACTURING PROCESS WERE FOUND IN THE PAST TWO YEARS. SIMULATION TEST: REGARDING THE FRACTURE OF THE GUIDEWIRE, THE FOLLOWING SIMULATION TEST WAS CONDUCTED. - CONTINUOUS TORQUE LOAD WAS APPLIED IN THE SAME DIRECTION WHILE THE PRODUCT IS CURVED - NO TAPERING IS OBSERVED ON THE SIDE OF THE WIRE STRAND AT THE FRACTURED PART. - RADIAL PATTERNS WERE OBSERVED ON THE TOP SURFACE OF THE WIRE STRAND AT THE FRACTURED PART. - IT WAS THOUGHT THAT THIS CONDITION WAS SIMILAR TO THAT OF THE ACTUAL DEVICE. [CAUSE OF OCCURRENCE]: BASED ON THE INVESTIGATION RESULTS, NO ANOMALY WAS FOUND IN DIMENSIONS OF THE ACTUAL DEVICE. BASED ON THE CONDITION OF THE ACTUAL DEVICE AND THE SIMULATION TEST, AS ONE OF THE POSSIBILITIES, IT WAS CONSIDERED THAT REPEATED TORQUE LOAD WAS APPLIED TO THE INVOLVED PART IN THE SAME DIRECTION WHILE IT WAS CURVED, LEADING TO THE FRACTURE OF THE WIRE STRAND. IT WAS THEN THOUGHT THAT THE OUTER LAYER TWISTED AND SEPARATED WITHIN THE BODY. ADDITIONALLY, REGARDING THE MISSING LENGTH, IT COULD NOT BE CLARIFIED IN DETAIL SINCE THE MAIN PART OF THE DEVICE WAS NOT RETURNED. FURTHERMORE, THE ACTUAL FRACTURED PIECE IS APPROXIMATELY 236MM, AND IT WAS CONSIDERED NOT TO BE DISCREPANT WITH THE COMPLAINT. RELEVANT IFU REFERENCE: "IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GLIDEWIRE AND/OR THE CATHETER AND DETERMINE THE CAUSE BY FLUOROSCOPY. 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 CORPORATION (TMC) (IMPORTER) REGISTRATION NO. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).
TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: AFTER REMOVING GALLBLADDER, THE PRODUCT WAS INSERTED INTO C TUBE OUT OF THE BODY FROM THE ABDOMINAL SIDE, AND THEN AN ATTEMPT WAS MADE TO ADVANCE THE GUIDEWIRE FROM DUODENAL PAPILLA TOWARD DUODENUM. IT HAD DIFFICULTY IN ADVANCING AND FELT IDLE ROTATING OF THE TORQUE HALFWAY THROUGH. THEN, IT WAS RECOGNIZED THAT APPROXIMATELY 20CM OF THE DISTAL END WAS SEPARATED. FORTUNATELY, IT WAS LEFT INSIDE THE C TUBE AND EVERYTHING COULD BE SUCCESSFULLY REMOVED BY RETRIEVING THE C TUBE. THE PROCEDURE OUTCOME WAS NOT REPORTED. THERE WAS NO HARM TO THE PATIENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 221290 | RADIFOCUS GUIDEWIRE M | WIRE, GUIDE, CATHETER | DQX | TERUMO CORPORATION, ASHITAKA | RF-GA25263 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention | MD-45706 C TUBE SET SB-KAWASUMI LABORATORIES, INC. |