ASAHI GLADIUS MG14 PV ES
Report
- Report Number
- 3003775027-2023-00112
- Event Type
- Injury
- Date Received
- November 9, 2023
- Date of Event
- October 3, 2023
- Report Date
- July 19, 2024
- Manufacturer
- ASAHI INTECC CO., LTD.
- Product Code
- DQX
- UDI-DI
- 04547327124775
- PMA / PMN Number
- K180784
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
UDI: RELATED DATA QUALITY UPDATES ONLY AS WE RECEIVED AN EMAIL TIME-STAMPED SATURDAY, (B)(6) 2024 1:27 AM AT OUR END FROM MR. (B)(6), MDR DATA SYSTEMS TEAM, TO INFORM US OF THE DISCREPANCIES IN THE DEVICE IDENTIFICATION FIELDS OF OUR SUBMITTED ELECTRONIC EQUIVALENT OF THE FDA FORM 3500A WHEN COMPARED WITH THE INFORMATION IN THE GUDID. THE REPORTED DEVICE IS SOLD OUTSIDE THE US IN A DIFFERENT BRAND NAME BUT IS SIMILAR IN STRUCTURE AND CONSTRUCTION AS A CURRENTLY US MARKETED DEVICE, ASAHI GLADIUS MONGO14 ES (K180784). AFTER COMPARING THE INFORMATION IN THE PREVIOUS SUBMITTED MDR WITH THAT OF ASAHI GLADIUS MONGO14 ES IN THE CORRESPONDING FIELDS IN THE GUDID, WE DETERMINED TO SUBMIT THIS SUPPLEMENTAL REPORT. THE CHANGES WE INTEND TO MAKE ARE AS FOLLOWS: D1: BRAND NAME - FROM GLADIUS MG 14 PV ES TO ASAHI GLADIUS MG14 PV ES. D3: MANUFACTURER NAME, CITY, AND STATE - FROM ASAHI INTECC CO., LTD. TO ASAHI INTECC CO., LTD. D4: MODEL # - FROM NO ENTRY TO PP14R304P. CATALOG # - FROM PP14R304P TO NO ENTRY. G1: CONTACT OFFICE - FROM ASAHI INTECC CO., LTD. TO ASAHI INTECC CO., LTD. H4: DEVICE MANUFACTURE DATE - FROM 24-7-2023 TO NO ENTRY.:
MANUFACTURING SITE: ASAHI INTECC (THAILAND) CO., LTD., PATHUM THANI, THAILAND, REGISTRATION NUMBER: 3003780911 THE REPORTED GLADIUS MG14 PV ES GUIDE WIRE AND ITS CONCOMITANTLY USED CORSAIR ARMET MICROCATHETER WERE RETURNED FOR INVESTIGATION. THE RETURNED GLADIUS MG14 PV ES GUIDE WIRE WAS FOUND INSERTED-IN THE CORSAIR ARMET MICROCATHETER. THE DISTAL SEGMENT OF THE GUIDE WIRE WAS COMING OUT OF THE MICROCATHETER TIP FOR APPROXIMATELY 55MM FROM THE GUIDE WIRE TIP. THE TWO DEVICES WERE STUCK TO EACH OTHER. MICROSCOPIC OBSERVATION FOUND THAT THE POLYMER JACKET OF THE GLADIUS MG14 PV ES GUIDE WIRE WAS PEELED AND GATHERED DISTALLY. X-RAY OBSERVATION FOUND NO SUCH DAMAGE AS KINK OF THE OUTER COIL OF THE GLADIUS MG14 PV ES IN THE CORSAIR ARMET MICROCATHETER. LOT HISTORY REVIEW REVEALED NO ANOMALY RELATING TO THE REPORTED EVENT. NO OTHER SIMILAR PRODUCT EXPERIENCE REPORT WAS RECEIVED FROM THIS LOT. BASED ON THE OBTAINED INFORMATION AND INVESTIGATION OUTCOME, IT WAS PRESUMED THAT THE SURFACE OF THE SUBJECT GLADIUS MG14 PV ES GUIDE WIRE MIGHT HAVE BEEN RUBBED FORCIBLY BY THE METALLIC TIP END OF THE CORSAIR ARMET MICROCATHETER DURING PUSHING MANIPULATION OF THE CONCOMITANT MICROCATHETER OR PUSHING AND PULLING MANIPULATION OF THE SUBJECT GUIDE WIRE WHILE THE DISTAL SEGMENT OF THE SUBJECT GLADIUS MG14 PV ES GUIDE WIRE HAD BEEN CURVED DUE TO VESSEL TORTUOSITY OR LESION CONDITIONS. CONSEQUENTLY, THE POLYMER JACKET OF THE SUBJECT GUIDE WIRE WAS SCRAPED AND PEELED. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. HOWEVER, IT WAS UNABLE TO COMPLETELY RULE OUT A POSSIBILITY THAT SOME FRAGMENTS OF THE PEELED POLYMER JACKET MIGHT REMAIN IN THE PATIENT ANATOMY. CAPA: NO CAPA WILL BE TAKEN. THE INSTRUCTIONS FOR USE (IFU) STATES: [CONTRAINDICATIONS] DO NOT USE THE GUIDE WIRE IN COMBINATION WITH CATHETERS (ATHERECTOMY CATHETER, METALLIC DILATOR ETC.) WHICH METALLIC PART MAY CONTACT SURFACE OF THIS GUIDE WIRE. [THIS GUIDE WIRE MAY BE DAMAGED OR SEPARATED.] [WARNINGS] OBSERVE GUIDE WIRE MOVEMENT IN THE VESSELS. BEFORE A GUIDE WIRE IS MOVED OR TORQUED, THE TIP MOVEMENT SHOULD BE EXAMINED AND MONITORED UNDER FLUOROSCOPY. DO NOT MOVE OR TORQUE A GUIDE WIRE WITHOUT OBSERVING CORRESPONDING MOVEMENT OF THE TIP. [OTHERWISE, THE GUIDE WIRE MAY BE DAMAGED AND/OR TRAUMA MAY OCCUR.] IN ADDITION, ENSURE THAT THE DISTAL GUIDE WIRE AND ITS LOCATION IN THE VESSEL ARE VISIBLE DURING WIRE MANIPULATION. NEVER PUSH, AUGER, WITHDRAW, OR TORQUE A GUIDE WIRE THAT MEETS RESISTANCE. TORQUING OR PUSHING A GUIDE WIRE AGAINST RESISTANCE MAY CAUSE GUIDE WIRE DAMAGE AND/OR GUIDE WIRE TIP SEPARATION OR DIRECT DAMAGE TO A VESSEL. RESISTANCE MAY BE FELT AND/OR OBSERVED UNDER FLUOROSCOPY BY NOTING ANY BUCKLING OF THE GUIDE WIRE TIP. IF GUIDE WIRE TIP PROLAPSE IS OBSERVED, DO NOT ALLOW THE TIP TO REMAIN IN A PROLAPSED POSITION. [OTHERWISE DAMAGE TO THE GUIDE WIRE MAY OCCUR.] DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE ANY NECESSARY REMEDIAL ACTION. [MALFUNCTIONS AND ADVERSE EFFECTS] ABRASION OF THE GUIDE WIRE COATING.
IT WAS REPORTED THAT THE POLYMER JACKET OF THE DISTAL SEGMENT OF AN ASAHI GLADIUS MG14 PV ES GUIDE WIRE WAS PEELED DISTAL TO THE TIP OF A CONCOMITANTLY USED ASAHI CORSAIR ARMET MICROCATHETER, AND THE TWO DEVICES GOT STUCK TO EACH OTHER DURING A PERCUTANEOUS PERIPHERAL INTERVENTION (PPI) FOR A CTO IN THE HEAVILY CALCIFIED ANTERIOR TIBIAL ARTERY (ATA). THE DEVICES WERE REMOVED FROM THE PATIENT ANATOMY AND REPLACED WITH A NEW SET OF DEVICES TO CONTINUE THE PROCEDURE, WHICH WAS COMPLETED WITH REESTABLISHED BLOOD FLOW BY WAY OF A PLAIN OLD BALLOON ANGIOPLASTY (POBA). IT WAS INFORMED THAT THERE WERE NO HEALTH HAZARDS CAUSED TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 93456 | ASAHI GLADIUS MG14 PV ES | PERIPHERAL GUIDE WIRE | DQX | ASAHI INTECC CO., LTD. | PP14R304P | 230718X122 | 04547327124775 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |