GLADIUS
Report
- Report Number
- 3003775027-2024-00023
- Event Type
- Injury
- Date Received
- February 26, 2024
- Date of Event
- January 12, 2024
- Report Date
- February 27, 2024
- Manufacturer
- ASAHI INTECC CO., LTD.
- Product Code
- DQX
- PMA / PMN Number
- K163426
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MANUFACTURING SITE: ASAHI INTECC (THAILAND) CO., LTD., PATHUM THANI, THAILAND, REGISTRATION NUMBER: 3003780911. DEVICE EVALUATION COULD NOT BE PERFORMED BECAUSE THE AFFECTED DEVICE WAS DISCARDED BY THE USER FACILITY. AN IMAGE OF THE AFFECTED GUIDE WIRE WAS OBTAINED, WHICH REVEALED THAT THE DISTAL SEGMENT OF THE GUIDE WIRE WAS WAVY AND THE POLYMER JACKET WAS INTERMITTENTLY TORN OFF. 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 IMAGE, RESULTS OF LOT HISTORY RECORDS REVIEW, AND REFERRING TO KNOWN SIMILAR EVENT, IT WAS PRESUMED THAT STRESS GENERATED WITH WIRE MANIPULATION MIGHT HAVE BEEN LOCALLY APPLIED ON THE TIP OF THE GLADIUS GUIDE WIRE WHILE THE WIRE TIP WAS CAUGHT BY THE LESION, FRACTURING THE CORE. FURTHER APPLIED TENSILE STRESS THEN CAUSED THE POLYMER JACKET TO BE STRETCHED AND TORN AS THE COIL WAS ELONGATED. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. ALTHOUGH NO ADVERSE PATIENT EFFECTS OCCURRED, IT WAS UNABLE TO COMPLETELY RULE OUT A POSSIBILITY THAT FRAGMENTED POLYMER JACKET MIGHT BE LEFT IN THE PATIENT ANATOMY. NO CAPA WILL BE TAKEN. INSTRUCTIONS FOR USE (IFU) STATES: [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 MANIPULATIONS. ~ 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. ~ IF ANY RESISTANCE IS FELT DUE TO SPASM OR THE GUIDE WIRE BEING BENT OR TRAPPED WHILE OPERATING THE GUIDE WIRE IN THE BLOOD VESSEL OR REMOVING IT, DO NOT MOVE OR TORQUE THE GUIDE WIRE. STOP THE PROCEDURE. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE APPROPRIATE REMEDIAL ACTION. IF THE GUIDE WIRE IS MOVED EXCESSIVELY, IT MAY BREAK OR BECOME DAMAGED, WHICH MAY CAUSE BLOOD VESSEL INJURY OR RESULT IN FRAGMENTS BEING LEFT INSIDE THE VESSEL. [MALFUNCTION AND ADVERSE EFFECTS] ~ BREAKAGE OF THE GUIDE WIRE.
IT WAS REPORTED THAT AN ASAHI GLADIUS GUIDE WIRE WAS USED DURING A PERCUTANEOUS PERIPHERAL INTERVENTION (PPI) TO TREAT AN UNSPECIFIED LESION IN THE PROXIMAL POSTERIOR TIBIAL ARTERY. RESISTANCE WAS MET DURING ADVANCEMENT OF THE GLADIUS GUIDE WIRE. AFTER REMOVAL, THE GUIDE WIRE WAS FOUND DAMAGED. THE PROCEDURE WAS THEN CONTINUED SUCCESSFULLY WITH ANOTHER GUIDE WIRE. THE PATIENT WAS REPORTEDLY STABLE WITH NO INJURY AFTER THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 102614 | GLADIUS | PERIPHERAL GUIDE WIRE | DQX | ASAHI INTECC CO., LTD. | NA | 230614A341 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Female | Other |