RADIFOCUS GLIDEWIRE
Report
- Report Number
- 9681834-2024-00135
- Event Type
- Injury
- Date Received
- July 31, 2024
- Date of Event
- June 20, 2024
- Report Date
- July 31, 2024
- 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 A3B: GENDER: REQUESTED, NOT PROVIDED A4: WEIGHT: REQUESTED, NOT PROVIDED A5: ETHNICITY: REQUESTED, NOT PROVIDED A6: RACE: REQUESTED, NOT PROVIDED D4: LOT #: REQUESTED, UNKNOWN D4: EXPIRATION DATE: UNKNOWN, AS THE INVOLVED PRODUCT LOT # WAS UNKNOWN D4: UDI: N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE INVOLVED PRODUCT LOT # WAS UNKNOWN G4: 510(K) NUMBER: K863138 & K926214 THE ACTUAL SAMPLE CONSISTED OF THE MAIN BODY OF THE GUIDEWIRE AND A FRAGMENT. A VISUAL INSPECTION OF THE ACTUAL SAMPLE WAS CONDUCTED. THE LENGTH OF THE FRAGMENT WAS APPROXIMATELY 10 MM, THE LENGTH OF THE MAIN BODY WAS APPROXIMATELY 1489 MM AND THE COMBINED LENGTH WAS APPROXIMATELY 1499 MM. THE COMBINED LENGTH WAS WITHIN OUR CONTROL CRITERIA FOR THIS PRODUCT CODE. A MAGNIFYING INSPECTION OF THE ACTUAL SAMPLE WAS CONDUCTED. THE CORE WIRE WAS EXPOSED IN BOTH FRACTURED PARTS. THERE WAS NO ANOMALY IN THE APPEARANCE, SUCH AS A PEELING OF OUTER LAYER, IN THE OTHER AREAS. ELECTRON MICROSCOPIC INSPECTION OF THE ACTUAL SAMPLE WAS CONDUCTED. WRINKLES WERE OBSERVED ON THE OUTER LAYER IN BOTH FRACTURED PARTS. THE FRACTURED EDGE OF THE OUTER LAYER OF BOTH PORTIONS SHOWED A TORN-LIKE SHAPE. SCRATCHES WERE OBSERVED NEAR THE FRACTURED PART OF THE FRAGMENT. THEREFORE, IT WAS INFERRED THAT SOME HARD OBJECT HAD COME INTO CONTACT WITH THE AREA IN QUESTION. THE OUTER DIAMETER (UNDAMAGED PARTS IN THE VICINITY OF THE FRACTURED PART) WAS CONFIRMED TO MEET THE FACTORY'S CONTROL CRITERIA. NO ANOMALY WAS FOUND. THE OUTER LAYER OF THE ACTUAL SAMPLE WAS REMOVED, AND THE FRACTURED ENDS OF THE CORE WIRE IN BOTH PORTIONS WERE INSPECTED USING ELECTRON MICROSCOPY. THE FRACTURED ENDS OF BOTH PORTIONS DID NOT EXHIBIT TAPERING, AND THE FRACTURE SURFACE APPEARED OBLIQUE. A DIMPLE PATTERN WAS OBSERVED ON A PART OF THE FRACTURE SURFACE OF BOTH PORTIONS. SINCE THE LOT # IS UNKNOWN, IT WAS NOT POSSIBLE TO INVESTIGATE THE MANUFACTURING RECORD AND PRODUCT INSPECTION RECORD. REGARDING THE PRODUCT CODE INVOLVED, THERE HAVE BEEN NO SIMILAR INCIDENTS DUE TO MANUFACTURING DEFECTS IN THE PAST TWO YEARS. SIMULATION TESTS WERE CONDUCTED TO EXAMINE THE GUIDEWIRE FRACTURE. WE HAVE OBSERVED THAT THE CORE WIRE FRACTURE'S CONDITION EXHIBITS REGULARITY DEPENDING ON THE MECHANISM THAT CAUSED IT. IN ONE OF THE SIMULATIONS, A CONTINUOUS BENDING FORCE AT A 180-DEGREE ANGLE WAS APPLIED WHILE THE DISTAL END WAS CONFINED. AS A RESULT, THE FRACTURED ENDS OF BOTH PORTIONS DID NOT TAPE, AND THE FRACTURE SURFACE SEEMED OBLIQUE. ALSO, A DIMPLE PATTERN WAS OBSERVED ON PART OF THE FRACTURE SURFACE. THIS CONDITION CLOSELY RESEMBLED THE ACTUAL SAMPLE. BASED ON THE SAMPLE'S CONDITION AND THE SIMULATION TEST RESULTS, IT CAN BE INFERRED THAT THE SAMPLE WAS SUBJECTED TO REPEATED BENDING LOADS AT A 180-DEGREE ANGLE WHILE TRAPPED IN A HARD OBJECT. THIS LED TO THE FRACTURE OF THE CORE WIRE AT APPROXIMATELY 10 MM FROM THE DISTAL END, LIKELY DUE TO METAL FATIGUE. SUBSEQUENTLY, WHEN THE SAMPLE WAS REMOVED, A PULLING FORCE WAS APPLIED, TEARING THE OUTER LAYER OFF. THIS RESULTED IN THE SAMPLE SEPARATING INTO MULTIPLE PORTIONS INSIDE THE PATIENT'S BODY. HOWEVER, SINCE THE COMBINED LENGTH OF THE RETURNED TWO PORTIONS FELL WITHIN THE FACTORY'S CONTROL CRITERIA, IT IS LIKELY THAT NO OTHER PORTION WAS MISSING FROM THE ACTUAL SAMPLE. RELEVANT IFU (INSTRUCTIONS FOR USE) 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 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 WHILE PASSING THE GUIDEWIRE TO RETRIEVE A BLOOD CLOT FROM THE SHUNT, THE DOCTOR FELT SLIGHT RESISTANCE. HOWEVER, SINCE ENCOUNTERING RESISTANCE IS COMMON WHEN COMING INTO CONTACT WITH A BLOOD CLOT, THE DOCTOR DID NOT FIND IT UNUSUAL. THE BLOOD CLOT RETRIEVAL PROCEDURE PROCEEDED SMOOTHLY. AT THE PROCEDURE'S END, WHEN THE RADIAL ARTERY AREA WAS EXAMINED UNDER FLUOROSCOPY, A BROKEN PIECE OF THE GUIDEWIRE WAS DISCOVERED IN THE WRIST AREA, SEPARATE FROM THE WIRE TIP. THE FRAGMENT SEEMED TRAPPED SOMEWHERE AND DID NOT MOVE, SUGGESTING IT WAS CAUGHT IN A BLOOD CLOT. IT WAS DETERMINED THAT THERE WAS NO POSSIBILITY OF THE FRAGMENT MIGRATING TO THE PERIPHERY. THE DOCTOR DID NOT FEEL THAT THE GUIDEWIRE HAD SNAPPED OFF DURING THE PROCEDURE. THE NEXT DAY, A SURGEON WAS CONSULTED TO REMOVE THE FRAGMENT. IT WAS FOUND TO BE PARTLY EMBEDDED IN THE BLOOD VESSEL WALL, BETWEEN THE BLOOD CLOT AND THE VESSEL WALL. THERE ARE NO ISSUES WITH THE PATIENT'S HEALTH. THE FRAGMENT WAS SURGICALLY REMOVED. THE EVENT OCCURRED INTRA-OPERATIVELY. THE PATIENT'S FINAL IMPACT WAS NO RESIDUE LEFT IN THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1979554 | RADIFOCUS GLIDEWIRE | WIRE, GUIDE, CATHETER | DQX | TERUMO CORPORATION, ASHITAKA | N/A | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |