RADIFOCUS GLIDEWIRE ADVANTAGE
Report
- Report Number
- 9681834-2023-00091
- Event Type
- Malfunction
- Date Received
- May 15, 2023
- Date of Event
- March 22, 2023
- Report Date
- May 15, 2023
- Manufacturer
- TERUMO MEDICAL CORPORATION
- Product Code
- DQX
- PMA / PMN Number
- K063372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
PATIENT IDENTIFIER: REQUESTED, UNKNOWN. DATE OF BIRTH: 1975. AGE: REQUESTED, UNKNOWN. WEIGHT: REQUESTED, UNKNOWN. ETHNICITY: REQUESTED, UNKNOWN. RACE: REQUESTED, UNKNOWN. 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): K122590, K163004. HEALTH PROFESSIONAL: UNKNOWN. OCCUPATION: OTHERS. THE RETURNED ITEMS WERE ONE ADVANTAGE (THE ACTUAL SAMPLE) AND A CONCURRENTLY USED NAVICROSS. VISUAL INSPECTION FOUND THAT THE POLYURETHANE JACKET HAD BEEN TURNED BACK DISTALLY AND THE LENGTH OF THE TURNED BACK PART WAS APPROXIMATELY 58 MM. THE DISTAL END OF THE GUIDEWIRE CORE WAS LOCATED AT APPROXIMATELY 44 MM FROM THE DISTAL END OF THE TURNED BACK OUTER LAYER. THEREFORE, THE OVERLAPPING PART OF THE POLYURETHANE JACKET WAS APPROXIMATELY 14 MM. THE LENGTH OF THE POLYURETHANE JACKET WAS APPROXIMATELY 261 MM. AS THE LENGTH OF THE SAME SECTION OF A CURRENT PRODUCT WAS APPROXIMATELY 250 MM, THE POLYURETHANE JACKET OF THE ACTUAL SAMPLE HAD BEEN STRETCHED BY APPROXIMATELY 11 MM. TURNED BACK PART OF POLYURETHANE JACKET WAS APPROXIMATELY 58MM. OVERLAPPING PART OF POLYURETHANE JACKET WAS APPROXIMATELY 14MM. POLYURETHANE JACKET AT THE PROXIMAL SIDE WAS APPROXIMATELY 189 MM. TOTAL LENGTH OF THE POLYURETHANE JACKET OF THE ACTUAL SAMPLE WAS APPROXIMATELY 261 MM (THE SAME SECTION OF A CURRENT PRODUCT SAMPLE WAS APPROXIMATELY 250 MM). THE CORE WAS EXPOSED APPROXIMATELY 47MM. IT WAS NOT POSSIBLE TO CLARIFY WHETHER THERE WAS ANY PART MISSING FROM THE POLYURETHANE JACKET BECAUSE IT WAS TORN. MAGNIFYING AND ELECTRON MICROSCOPIC INSPECTION OF THE POLYURETHANE JACKET SECTION FOUND THAT THERE WERE FINE CRACKS ON THE INNER SURFACE OF THE POLYURETHANE JACKET. FROM THIS, IT WAS PRESUMED THAT TENSILE FORCE WAS APPLIED IN THE DISTAL DIRECTION. THERE ARE SCRATCHES IN THE VICINITY OF THE CUT PART OF THE POLYURETHANE JACKET. FROM THIS, IT WAS PRESUMED THE ABRASION FORCE WAS APPLIED. MAGNIFYING INSPECTION OF THE PTFE COATING SECTION FOUND THAT THERE WAS NO APPEARANCE ANOMALY SUCH AS SCRATCHES OR PEELED COATING. OUTER DIAMETER OF THE DISTAL END MET THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND. OUTER DIAMETER OF THE PTFE COATING SECTION MET THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND. INSPECTION OF NAVICROSS: MAGNIFYING INSPECTION FOUND IT WAS CURVED AT APPROXIMATELY 485 MM FROM THE DISTAL END AND KINKED AT APPROXIMATELY 530 MM FROM THE DISTAL END. OUTER DIAMETER MET THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND. INNER DIAMETER AT THE DISTAL SECTION MET THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND. INNER DIAMETER AT THE PROXIMAL SECTION MET THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND. A COMBINATION TEST WAS PERFORMED. AN ATTEMPT TO INSERT THE NAVICROSS OVER THE ACTUAL SAMPLE FROM THE PROXIMAL END WAS MADE, AND THE NAVICROSS WAS STUCK AT THE TIME WHEN INSERTED APPROXIMATELY 33 MM. X-RAY FLUOROSCOPIC INSPECTION OF THE LUMEN OF NAVICROSS. THE MARKER WIRE WAS JUMBLED IN THE DISTAL SIDE FROM THE SECOND COIL MARKER BAND LOCATED AT APPROXIMATELY 40 MM FROM THE DISTAL END. FROM THIS, IT WAS PRESUMED THAT THE STICKING OF NAVICROSS OCCURRED AT APPROXIMATELY 33 MM FROM THE PROXIMAL END OF THE ACTUAL SAMPLE DURING THE ABOVE COMBINATION TEST. A SIMULATION TEST WAS PERFORMED. IT WAS ASSUMED FROM THE STATE OF THE ACTUAL SAMPLE THAT, WHEN THE ACTUAL SAMPLE WAS MANIPULATED IN THE WITHDRAWAL DIRECTION, THE URETHANE JACKET WAS EXPOSED TO SOME OBJECT, CAUGHT ON IT, AND TURNED BACK. THEREFORE, WE PERFORMED A SIMULATION TEST ASSUMING THAT A STARTING POINT OF STICKING (DAMAGE DUE TO ABRASION, ETC.) OCCURRED DURING MANIPULATION OF THE ACTUAL SAMPLE. AN ADVANTAGE WITH A SCRATCH ON THE POLYURETHANE JACKET WAS ONCE COMBINED WITH A CATHETER, AND THEN THE ADVANTAGE WAS REMOVED. THE CATHETER GOT CAUGHT ON THE SCRATCH. THE ADVANTAGE IN THAT STATE WAS WITHDRAWN FURTHER. THE POLYURETHANE JACKET STARTED TO TURN BACK IN THE DISTAL DIRECTION. THE CORE WAS EXPOSED DUE TO TURNED BACK POLYURETHANE JACKET. THE STATE OF THE TEST SAMPLE WAS SIMILAR TO THE STATE OF THE ACTUAL PRODUCT. MANUFACTURING RECORD AND SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE FOUND NO ANOMALY. PAST COMPLAINT FILE OF THE INVOLVED PRODUCT CODE/LOT, NO OTHER SIMILAR COMPLAINT WAS REPORTED FROM OTHER FACILITIES. BASED ON THE INVESTIGATION RESULT, THE FOLLOWING MECHANISM WAS INFERRED AS A POSSIBLE CAUSE OF THIS CASE. A SCRATCH WAS CAUSED ON THE INVOLVED AREA OF THE ACTUAL SAMPLE DUE TO SOME FACTORS SUCH AS STENOTIC LESION. THE ACTUAL SAMPLE IN THAT SCRATCHED STATE WAS INSERTED FROM THE PROXIMAL END IN THE NAVICROSS. THE NAVICROSS WAS CAUGHT ON THE SCRATCHED PART OF THE ACTUAL SAMPLE AND WOULD NOT ADVANCE FURTHER. EXCESSIVE FORCE TO PULL OUT THE ACTUAL SAMPLE OR PUSH FORWARD THE NAVICROSS WAS APPLIED, WHICH RESULTED THAT THE POLYURETHANE JACKET GOT TURNED BACK IN THE DISTAL DIRECTION. WHEN THE TURNED BACK PART OF URETHANE JACKET WAS DRAWN INSIDE THE NAVICROSS, ABRASION FORCE WAS APPLIED TO THE INNER LAYER OF NAVICROSS, CAUSING DAMAGE TO THE INNER LAYER AND JUMBLING OF MARKER WIRE, WHICH RESULTED IN THE STICKING. *AS FOR THE KINK AND BEND ON THE NAVICROSS, IT WAS NOT POSSIBLE TO CLARIFY THE TIMING OF OCCURRENCE, HOWEVER, IT WAS CONFIRMED DURING THE INVESTIGATION THAT THE FACTORY-RETAINED ADVANTAGE SAMPLE WAS POSSIBLE TO PASS THROUGH THE KINKED/BENT AREAS WITHOUT RESISTANCE, THEREFORE, THE KINK AND BEND WERE NOT CONSIDERED TO BE THE DIRECT FACTORS OF THE STICKING PHENOMENON. RELEVANT INSTRUCTIONS FOR USE (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." "FLUSH IT BY INJECTING HEPARINIZED SALINE SOLUTION THROUGH THE CATHETER HUB USING A SYRINGE." 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 HIGH FRICTION WITH THE RADIFOCUS GLIDEWIRE ADVANTAGE (GWA) INVOLVED. ACCESS WAS TRANS FEMORAL LEFT WITH ANTEGRADE PUNCTURE USING A MINI GUIDE WIRE, THEN INSERTION OF A 6 FRENCH SHEATH AND OF A GWA 18 WIRE. THE PATIENT WAS VERY OBESE; THEREFORE, THE POSITION OF THE SHEATH WAS NOT OPTIMAL AND ESPECIALLY THE ANGLE IN THE VESSEL. THE GWA WAS DIFFICULT TO ADVANCE IN THE VESSEL. FOR BETTER SUPPORT, A NAVICROSS 18 135 CM WAS INSERTED WHICH GOT STUCK ON THE WIRE BEFORE REACHING THE TARGET LESION. IT WAS LIKELY THAT THE HYDROPHILIC COATING GOT DAMAGED BY THE SHEATH (BECAUSE OF THE ANGLE OF THE SHEATH). IT WAS ONLY POSSIBLE TO REMOVE BOTH PRODUCTS TOGETHER. PIECES OF THE GUIDEWIRE COATING WERE NOT LOOSE INSIDE THE PATIENT. TWO NEW DEVICES WERE USED, AND THE PROCEDURE COULD BE FINISHED SUCCESSFULLY. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETELY SUCCESSFULLY. NO RESIDUES WERE IN THE PATIENT'S BODY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1405867 | RADIFOCUS GLIDEWIRE ADVANTAGE | WIRE, GUIDE, CATHETER | DQX | TERUMO MEDICAL CORPORATION | N/A | 221101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | NAVICROSS(PN*NA180N3HM)| RADIFOCUS INTRODUCER II STANDARD KIT B RS+B60N10MQ |