RADIFOCUS GUIDEWIRE M
Report
- Report Number
- 9681834-2022-00063
- Event Type
- Injury
- Date Received
- April 14, 2022
- Date of Event
- March 16, 2022
- Report Date
- April 14, 2022
- 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
PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED. AGE & DATE OF BIRTH: REQUESTED, NOT PROVIDED. PATIENT SEX: REQUESTED, NOT PROVIDED. WEIGHT: REQUESTED, NOT PROVIDED. ETHNICITY: REQUESTED, NOT PROVIDED. RACE: REQUESTED, NOT PROVIDED. 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. PMA/510(K): K863138, K926214. THE ACTUAL SAMPLES WERE RETURNED UPON RECEIPT WERE OUR GUIDEWIRE (ACTUAL SAMPLE) AND A COMPETITOR'S CATHETER (COMPETITOR'S SAMPLE). VISUAL INSPECTION OBTAINED FOLLOWING RESULTS: THE LENGTH OF FRACTURED PIECE WAS APPROX. 455MM, AND THE LENGTH OF MAIN BODY WAS APPROX. 1045MM. SINCE THE LENGTH OF NORMAL PRODUCT IS APPROX. 1500MM, THE TOTAL LENGTH OF ACTUAL SAMPLE WAS EQUIVALENT TO THE NORMAL PRODUCT: IT HAD BEEN KINKED AT APPROX. 445MM FROM THE DISTAL END OF FRACTURED PIECE. MAGNIFYING INSPECTION OBTAINED FOLLOWING RESULTS: A CONTACT MARK WAS FOUND ON THE KINKED SECTION OF FRACTURED PIECE; IT HAD BEEN SCRATCHED IN THE VICINITY OF KINKED SECTION OF THE FRACTURED PIECE, AND THE WIRE HAD BEEN PARTIALLY EXPOSED; THE WIRE HAD BEEN EXPOSED AT THE FRACTURED SECTION ON THE FRACTURED PIECE SIDE; THE OUTER LAYER OF FRACTURED SECTION ON THE MAIN BODY SIDE HAD BEEN ELONGATED. ELECTRON MICROSCOPIC INSPECTION OBTAINED FOLLOWING RESULTS: A SHAPE THAT SEEMED TO HAVE BEEN PUSHED WAS FOUND INSIDE THE KINKED SECTION OF FRACTURED PIECE; THE KINKED SECTION OF FRACTURED PIECE HAD BEEN DENTED, AND HAD BEEN WRINKLED IN THE CIRCUMFERENTIAL DIRECTION; THE SCRATCHES IN THE VICINITY OF KINKED SECTION OF THE FRACTURED PIECE OCCURRED TOWARD THE DISTAL SIDE, AND WRINKLES IN THE LONGITUDINAL DIRECTION WERE FOUND; WRINKLES WERE FOUND ON THE OUTER LAYER OF FRACTURED SECTION ON THE FRACTURED PIECE SIDE AND THE MAIN BODY SIDE. THE OUTER DIAMETER (NORMAL SECTION) WAS MEASURED AND CONFIRMED TO MEET THE SPECIFICATIONS. THE OUTER LAYER WAS REMOVED AND ELECTRON MICROSCOPIC INSPECTION FOR THE WIRE STATE WAS PERFORMED. FOLLOWING RESULTS WERE OBTAINED: THE SHAPES OF THE WIRE FRACTURED SECTION AND THE FRACTURE SURFACE WERE DIFFERENT BETWEEN THE FRACTURED PIECE SIDE AND THE MAIN BODY SIDE; THE FRACTURED SECTION OF WIRE WAS FLAT ON THE FRACTURED PIECE SIDE, WHILE ITS MAIN BODY SIDE WAS SHAPED LIKE IT WAS PINCHED; A RADIAL PATTERN WAS FOUND ON THE FRACTURE SURFACE OF WIRE ON THE FRACTURED PIECE SIDE; STREAKS, STEPS, AND SMOOTH PARTS WERE PARTIALLY FOUND ON THE FRACTURE SURFACE OF WIRE ON THE MAIN BODY SIDE. REVIEW OF THE MANUFACTURING RECORD AND THE PRODUCT RELEASE DECISION CONTROL SHEET CONFIRMED THAT THERE WERE NOT ANY INDICATIONS OF ANOMALY IN THEM. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER SIMILAR REPORT WITH THE INVOLVED PRODUCT CODE/LOT# COMBINATION FROM OTHER FACILITIES. IN ASHITAKA FACTORY, THE FOLLOWING SIMULATION TEST WAS PERFORMED FOR THE FRACTURE OF GUIDEWIRE, AND WE HAVE BEEN AWARE THAT THERE IS REGULARITY IN THE WIRE STATE DEPENDING ON THE MECHANISM LEADING TO THE FRACTURE. WHEN CONTINUOUS TORQUE FORCE WAS APPLIED IN THE SAME DIRECTION WHILE THE GUIDEWIRE WAS CURVED: CONTINUOUS TORQUE FORCE WAS APPLIED IN THE SAME DIRECTION UNTIL FRACTURING OCCURRED. NO TAPER WAS FOUND ON THE FRACTURED SECTION OF WIRE, IT WAS FLAT, AND RADIAL PATTERNS WERE FOUND ON THE FRACTURE SURFACE OF WIRE. IT WAS LIKELY TO BE SIMILAR TO THE ACTUAL SAMPLE. WHEN REPEATED BENDING FORCE WAS APPLIED: 90 ° FOLDED BENDING FORCE WAS CONTINUOUSLY APPLIED UNTIL FRACTURING OCCURRED; NO TAPER WAS FOUND ON THE FRACTURED SECTION OF WIRE, AND A DIMPLE PATTERN (A HOLE-SHAPED PATTERN) WAS FOUND ON THE FRACTURE SURFACE OF WIRE. IT WAS LIKELY THAT THE MECHANISM OF OCCURRENCE WAS DIFFERENT FROM THE ACTUAL SAMPLE. WHEN PULLING FORCE WAS APPLIED: PULLING FORCE WAS APPLIED UNTIL FRACTURING OCCURRED; THE FRACTURED SECTION OF WIRE WAS TAPERED. IT WAS LIKELY THAT THE MECHANISM OF OCCURRENCE WAS DIFFERENT FROM THE ACTUAL SAMPLE; WHEN PULLING FORCE WAS APPLIED IN A LOOPED STATE; (IV) PULLING FORCE WAS APPLIED IN A LOOPED STATE UNTIL FRACTURING OCCURRED; (V) THE FRACTURED SECTION OF WIRE WAS CURVED AND TAPERED, AND THE FRACTURE SURFACE OF WIRE WAS ROUGH. IT WAS LIKELY THAT THE MECHANISM OF OCCURRENCE WAS DIFFERENT FROM THE ACTUAL SAMPLE. WHEN PULLING FORCE WAS APPLIED IN A LOOPED STATE; PULLING FORCE WAS APPLIED IN A LOOPED STATE UNTIL FRACTURING OCCURRED; (II) THE FRACTURED SECTION OF WIRE WAS CURVED AND TAPERED, AND THE FRACTURE SURFACE OF WIRE WAS ROUGH. IT WAS LIKELY THAT THE MECHANISM OF OCCURRENCE WAS DIFFERENT FROM THE ACTUAL SAMPLE. INSPECTION OF THE COMPETITOR'S SAMPLE: VISUAL INSPECTION FOUND THAT IT HAD BEEN DEFORMED. UNDER MAGNIFYING INSPECTION FOUND A DENT AND A FLARE FROM THE INSIDE TO THE OUTSIDE. BASED ON THE INVESTIGATION RESULT AND THE SIMULATION TEST RESULT, IT WAS LIKELY THAT CONTINUOUS TORQUE OPERATION WAS APPLIED IN A CURVED STATE, AND IT WAS FRACTURED AT A POSITION OF APPROX. 455MM FROM THE DISTAL END. REGARDING THE FACT THAT THE WIRE STATE WAS DIFFERENT BETWEEN THE FRACTURED PIECE SIDE AND THE MAIN BODY SIDE, IT WAS PRESUMED THAT SOME FORCE WAS APPLIED TO THE WIRE OF MAIN BODY AFTER THE FRACTURE. HOWEVER, SINCE THE DETAILS OF OCCURRENCE SITUATION WERE UNKNOWN, WE ARE VERY SORRY, BUT WE COULD NOT IDENTIFY THE CAUSE OF OCCURRENCE. IN ADDITION, SINCE THE TOTAL LENGTH OF ACTUAL SAMPLE WAS EQUIVALENT TO THAT OF THE NORMAL PRODUCT, NO SPECIFIC MISSING WAS FOUND IN THE ACTUAL SAMPLE. AS FOR THE KINK ON THE FRACTURED PIECE AND THE SCRATCHES IN THE VICINITY OF FRACTURED PIECE OF THE ACTUAL SAMPLE, SINCE DEFORMATION WAS FOUND IN THE COMPETITOR'S SAMPLE, IT WAS PRESUMED THAT THERE WAS A STRONG CONTACT WHEN THE FRACTURED PIECE WAS PULLED INTO THE COMPETITOR'S SAMPLE IN ORDER TO RETRIEVE THE FRACTURED PIECE. HOWEVER, SINCE THERE WAS NO DETAILED INFORMATION AT THE TIME OF RETRIEVING AND NO TECHNICAL INFORMATION OF THE COMPETITOR'S SAMPLE WAS OBTAINED, THE CAUSE OF OCCURRENCE COULD NOT BE CLARIFIED. 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 NO. 1 TO CORRECT SECTION B5, SECTION D4 LOT NUMBER AND SECTION H4.
THE USER FACILITY REPORTED THAT THE INVOLVED RADIFOCUS GUIDEWIRE M PRODUCT WAS PRIMED AFTER OPENING THE PACKAGE. WHEN THE WIRE WAS TAKEN OUT, IT WAS FOUND THAT THE URETHANE HAD PEELED OFF AT THE DISTAL END. IT WAS INFERRED THAT THE EVENT WAS AN INITIAL FAILURE, AND ANOTHER PRODUCT WAS USED TO FINISH THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO HARM TO THE PATIENT.
THE USER FACILITY REPORTED THAT THE INVOLVED THE INVOLVED PRODUCT WAS USED FOR SHUNT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE ADVANCING IN THE SHUNT WAS HAIRPIN SHAPE, AND HIGH CALCIFICATION WAS OBSERVED AT THE ANASTOMOTIC SECTION. WHEN THE SUCTION CATHETER WAS DELIVERED INTO THE SHUNT USING THE INVOLVED PRODUCT AND A PUSH-PULL OPERATION WAS APPLIED SEVERAL TIMES, THE PRODUCT WAS FRACTURED. THE FRACTURED PIECE IN THE SHUNT WAS SUCCESSFULLY RETRIEVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 140467 | RADIFOCUS GUIDEWIRE M | WIRE, GUIDE, CATHETER | DQX | TERUMO CORPORATION, ASHITAKA | NA | 210907 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |